{"id":17219,"date":"2022-05-03T13:57:26","date_gmt":"2022-05-03T08:27:26","guid":{"rendered":"https:\/\/www.delveinsight.com\/blog\/?p=17219"},"modified":"2022-06-14T09:25:58","modified_gmt":"2022-06-14T03:55:58","slug":"pharma-news-for-astrazeneca-bms-merck","status":"publish","type":"post","link":"https:\/\/www.delveinsight.com\/blog\/pharma-news-for-astrazeneca-bms-merck","title":{"rendered":"VBL Therapeutics\u2019 VB-111 (ofranergene obadenovec); BMS\u2019s mavacamten (Camzyos); Merck\u2019s KEYTRUDA; AstraZeneca and Daiichi\u2019s Enhertu; Pfizer\/Biohaven\u2019s VYDURA (rimegepant); AstraZeneca\u2019s Ultomiris; Supernus\u2019s Viloxazine (Qlebree); AbbVie\u2019s Rinvoq"},"content":{"rendered":"<div id=\"ez-toc-container\" class=\"ez-toc-v2_0_76 counter-hierarchy ez-toc-counter ez-toc-white ez-toc-container-direction\">\n<p class=\"ez-toc-title\" style=\"cursor:inherit\">Table of Contents<\/p>\n<label for=\"ez-toc-cssicon-toggle-item-6a121333724cc\" class=\"ez-toc-cssicon-toggle-label\"><span class=\"\"><span class=\"eztoc-hide\" style=\"display:none;\">Toggle<\/span><span class=\"ez-toc-icon-toggle-span\"><svg style=\"fill: #999;color:#999\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\" class=\"list-377408\" width=\"20px\" height=\"20px\" viewBox=\"0 0 24 24\" fill=\"none\"><path d=\"M6 6H4v2h2V6zm14 0H8v2h12V6zM4 11h2v2H4v-2zm16 0H8v2h12v-2zM4 16h2v2H4v-2zm16 0H8v2h12v-2z\" fill=\"currentColor\"><\/path><\/svg><svg style=\"fill: #999;color:#999\" class=\"arrow-unsorted-368013\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\" width=\"10px\" height=\"10px\" viewBox=\"0 0 24 24\" version=\"1.2\" baseProfile=\"tiny\"><path d=\"M18.2 9.3l-6.2-6.3-6.2 6.3c-.2.2-.3.4-.3.7s.1.5.3.7c.2.2.4.3.7.3h11c.3 0 .5-.1.7-.3.2-.2.3-.5.3-.7s-.1-.5-.3-.7zM5.8 14.7l6.2 6.3 6.2-6.3c.2-.2.3-.5.3-.7s-.1-.5-.3-.7c-.2-.2-.4-.3-.7-.3h-11c-.3 0-.5.1-.7.3-.2.2-.3.5-.3.7s.1.5.3.7z\"\/><\/svg><\/span><\/span><\/label><input type=\"checkbox\"  id=\"ez-toc-cssicon-toggle-item-6a121333724cc\"  aria-label=\"Toggle\" \/><nav><ul class='ez-toc-list ez-toc-list-level-1 ' ><li class='ez-toc-page-1 ez-toc-heading-level-2'><a class=\"ez-toc-link ez-toc-heading-1\" href=\"https:\/\/www.delveinsight.com\/blog\/pharma-news-for-astrazeneca-bms-merck\/#FDA_Grants_Fast_Track_Designation_to_VB-111_for_Platinium-resistant_Ovarian_Cancer\" >FDA Grants Fast Track Designation to VB-111 for Platinium-resistant Ovarian Cancer<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-2'><a class=\"ez-toc-link ez-toc-heading-2\" href=\"https:\/\/www.delveinsight.com\/blog\/pharma-news-for-astrazeneca-bms-merck\/#FDA_Approves_Bristol-Myers_Squibbs_Cardiomyopathy_Drug_Mavacamten\" >FDA Approves Bristol-Myers Squibb\u2019s Cardiomyopathy Drug Mavacamten<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-2'><a class=\"ez-toc-link ez-toc-heading-3\" href=\"https:\/\/www.delveinsight.com\/blog\/pharma-news-for-astrazeneca-bms-merck\/#European_Commission_Approves_PembrolizumabChemotherapy_With_or_Without_Bevacizumab_for_PD-L1_Metastatic_Cervical_Cancer\" >European Commission Approves Pembrolizumab\/Chemotherapy With or Without Bevacizumab for PD-L1+ Metastatic Cervical Cancer<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-2'><a class=\"ez-toc-link ez-toc-heading-4\" href=\"https:\/\/www.delveinsight.com\/blog\/pharma-news-for-astrazeneca-bms-merck\/#AstraZeneca_and_Daiichi_Sankyos_Enhertu_Gets_Breakthrough_Designation_for_HER2-low_Breast_Cancer\" >AstraZeneca and Daiichi Sankyo\u2019s Enhertu Gets Breakthrough Designation for HER2-low Breast Cancer<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-2'><a class=\"ez-toc-link ez-toc-heading-5\" href=\"https:\/\/www.delveinsight.com\/blog\/pharma-news-for-astrazeneca-bms-merck\/#European_Commission_Approves_PfizerBiohaven_Migraine_Drug_Rimegepant\" >European Commission Approves Pfizer\/Biohaven Migraine Drug Rimegepant<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-2'><a class=\"ez-toc-link ez-toc-heading-6\" href=\"https:\/\/www.delveinsight.com\/blog\/pharma-news-for-astrazeneca-bms-merck\/#AstraZenecas_Ultomiris_Receives_its_Third_FDA_Approval\" >AstraZeneca\u2019s Ultomiris Receives its Third FDA Approval<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-2'><a class=\"ez-toc-link ez-toc-heading-7\" href=\"https:\/\/www.delveinsight.com\/blog\/pharma-news-for-astrazeneca-bms-merck\/#FDA_Approves_Viloxazine_Capsules_for_Adults_with_ADHD\" >FDA Approves Viloxazine Capsules for Adults with ADHD<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-2'><a class=\"ez-toc-link ez-toc-heading-8\" href=\"https:\/\/www.delveinsight.com\/blog\/pharma-news-for-astrazeneca-bms-merck\/#FDA_Approves_Rinvoq_for_Adults_with_Ankylosing_Spondylitis\" >FDA Approves Rinvoq for Adults with Ankylosing Spondylitis<\/a><\/li><\/ul><\/nav><\/div>\n\n<h2 class=\"wp-block-heading\" id=\"h-fda-grants-fast-track-designation-to-vb-111-for-platinium-resistant-ovarian-cancer\"><span class=\"ez-toc-section\" id=\"FDA_Grants_Fast_Track_Designation_to_VB-111_for_Platinium-resistant_Ovarian_Cancer\"><\/span><strong>FDA Grants Fast Track Designation to VB-111 for Platinium-resistant Ovarian Cancer<\/strong><span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p>The FDA has given <strong>VBL Therapeutics\u2019 VB-111 (ofranergene obadenovec)<\/strong>, a targeted anticancer viral gene therapy, fast track designation for use as a viable therapeutic option in patients with platinum-resistant Ovarian Cancer.<\/p>\n\n\n\n<p><strong>VB-111<\/strong> is intended to target a wide spectrum of solid tumors, including ovarian cancer, using a dual mechanism. The strategy combines tumor vascular blockage with an anticancer immune response. Prior findings from a <strong>phase 1\/2 trial<\/strong> showed that VB-111 coupled with paclitaxel was efficacious and safe in this patient population.<\/p>\n\n\n\n<p>Approximately half of the <strong>21 patients<\/strong> enrolled in the trial had platinum-refractory disease, and the other half had already undergone antiangiogenic therapy. Despite these negative prognostic factors, <strong>58% <\/strong>of evaluable patients had CA-125 responses. Furthermore, the median overall survival (OS) in those who received the agent at the therapeutic dose of <strong>1 x 1013 viral particles<\/strong> plus paclitaxel at <strong>80 mg\/m2 (n = 17)<\/strong> was <strong>498 days <\/strong>compared to <strong>172.5 days <\/strong>in those who received the agent at the sub-therapeutic dose of <strong>3 x 1012 viral particles<\/strong> plus paclitaxel at <strong>40 mg\/m2 to 80 mg\/m2 (n = 4; P =.03). <\/strong>The combination is being investigated further in the <strong>phase 3 OVAL trial,<\/strong> where it is being compared to paclitaxel alone in <a href=\"https:\/\/www.delveinsight.com\/report-store\/platinum-resistant-relapsed-ovarian-cancer-market\">patients with recurrent platinum-resistant Ovarian Cancer<\/a>.<\/p>\n\n\n\n<p><strong>OVAL<\/strong> just finished enrolling <strong>409 participants<\/strong>, and the trial is being conducted at cancer centers across the United States, Europe, Israel, and Japan. The primary endpoints of the trial were OS and PFS, with supplementary endpoints including combined <strong>CA-125 and RECIST v1.1 response<\/strong>, CA-125 response, objective response rate per <strong>RECIST v1.1 criteria, and OS100 <\/strong>for sensitivity analysis of OS.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"FDA_Approves_Bristol-Myers_Squibbs_Cardiomyopathy_Drug_Mavacamten\"><\/span><strong>FDA Approves Bristol-Myers Squibb\u2019s Cardiomyopathy Drug Mavacamten<\/strong><span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p><strong>Bristol-Myers Squibb<\/strong> has become the first company to obtain FDA approval for a cardiac myosin inhibitor, claiming approval for mavacamten as a <a href=\"https:\/\/www.delveinsight.com\/report-store\/obstructive-hypertrophic-cardiomyopathy-hcm-pipeline-insight\">therapy for Obstructive Hypertrophic Cardiomyopathy (HCM)<\/a>. Orally-active <strong>mavacamten<\/strong>, which BMS purchased in a deal of <strong>USD 13 billion<\/strong> from <strong>MyoKardia <\/strong>in 2020, will be launched under the <strong>Camzyos <\/strong>brand name, with a list price of <strong>USD 89,500<\/strong> per year.<\/p>\n\n\n\n<p>According to the company, <strong>Camzyos <\/strong>is the first drug to address the underlying disease pathology in obstructive HCM, a degenerative disease that thickens the heart walls, making it difficult for the heart to expand correctly and fill with blood. The disease affects one in every <strong>500 persons<\/strong> in the United States and around <strong>400,000-600,000<\/strong> people globally, albeit it is underdiagnosed. If not treated properly, it can progress to atrial fibrillation, stroke, and heart failure.<\/p>\n\n\n\n<p>The approval was based on the <strong>EXPLORER-HCM trial<\/strong>, which included <strong>251 patients<\/strong> with NYHA class II or III obstructive HCM and a left ventricular ejection fraction (LVEF) of <strong>55%<\/strong> or above. After <strong>30 weeks<\/strong> of treatment with the oral medicine, <strong>37%<\/strong> of patients taking mavacamten had accomplished the study&#8217;s primary goal, compared to <strong>17%<\/strong> of the placebo group. Patients were considered to have met the treatment goal if they had a <strong>1.5 point<\/strong> or more increase on a peak oxygen consumption (pV02) scale and at least one NYHA class reduction or if they had a <strong>3 point<\/strong> increase with no NYHA class worsening.<\/p>\n\n\n\n<p>Since BMS submitted mavacamten for approval, the drug has also produced positive results in the <strong>VALOR-HCM trial<\/strong> in patients with obstructive HCM who require septal reduction therapy (SRT), adding to its evidence base. The approval strengthens <strong>BMS&#8217;<\/strong> advantage over <strong>Cytokinetics<\/strong>, its closest competitor in the cardiac myosin inhibitor class, whose rival medicine <strong>CK-274<\/strong> cleared a <strong>phase 2 trial<\/strong> last year and is now in a phase 3 program.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"European_Commission_Approves_PembrolizumabChemotherapy_With_or_Without_Bevacizumab_for_PD-L1_Metastatic_Cervical_Cancer\"><\/span><strong>European Commission Approves Pembrolizumab\/Chemotherapy With or Without Bevacizumab for PD-L1+ Metastatic Cervical Cancer<\/strong><span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p><strong>Merck <\/strong>today announced that the <strong>European Commission<\/strong> had approved <strong>KEYTRUDA<\/strong>, Merck&#8217;s <strong>anti-PD-1 therapy<\/strong>, in combination with chemotherapy, with or without <a href=\"https:\/\/www.delveinsight.com\/report-store\/bevacizumab-biosimilars-insight\"><strong>bevacizumab<\/strong><\/a>, to treat persistent, recurrent, or metastatic cervical cancer in adults whose tumors express PD-L1. The approval is established on the results from the <strong>Phase III KEYNOTE-826 trial<\/strong>. KEYTRUDA, in combination with chemotherapy with\/without bevacizumab, demonstrated a statistically compelling improvement in overall survival progression-free survival compared to chemotherapy with\/without bevacizumab in this patient population. In addition to this, more patients reciprocated to the KEYTRUDA regimen, with an objective response rate of <strong>68%<\/strong> versus <strong>50%<\/strong>, respectively.<\/p>\n\n\n\n<p>&#8220;After years of limited progress in developing treatment options for <strong>persistent, recurrent, or metastatic cervical cancer<\/strong>, we saw evident advancements in overall survival in KEYNOTE-826, with a <strong>36%<\/strong> reduction in the risk of death,&#8221; said Dr. Nicoletta Colombo. &#8220;With today&#8217;s approval, healthcare providers in the European Union will be able to offer certain patients with advanced cervical cancer a long-awaited immunotherapy option that has shown significant improvement in overall survival.&#8221;<\/p>\n\n\n\n<p>&#8220;Women diagnosed with persistent, recurrent or metastatic cervical cancer often have a low survival rate,&#8221; said Dr. Gursel Aktan, vice president, global clinical development, Merck Research Laboratories. &#8220;The EU approval of this KEYTRUDA regimen for women with persistent, recurrent or metastatic cervical cancer whose tumors express <strong>PD-L1 CPS \u22651<\/strong> is the first of its kind for an immunotherapy regimen in Europe and is another example of our continued commitment to delivering new therapies for patients with <strong>breast cancers<\/strong> and <strong>gynecologic cancers<\/strong>.&#8221;<\/p>\n\n\n\n<p>Merck is rapidly expanding its extensive clinical development program for KEYTRUDA and several other investigational and approved medicines across gynecologic cancers, including evaluating KEYTRUDA to treat locally advanced cervical cancer.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"AstraZeneca_and_Daiichi_Sankyos_Enhertu_Gets_Breakthrough_Designation_for_HER2-low_Breast_Cancer\"><\/span><strong>AstraZeneca and Daiichi Sankyo\u2019s Enhertu Gets Breakthrough Designation for HER2-low Breast Cancer<\/strong><span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p><strong>AstraZeneca<\/strong> and <strong>Daiichi Sankyo <\/strong>have claimed a fifth breakthrough designation from the FDA for <strong>Enhertu<\/strong>, shortly after showing the extended drug survival in <a href=\"https:\/\/www.delveinsight.com\/report-store\/her2-negative-metastatic-breast-cancer-pipeline-insight\">patients with <strong>HER2-Low Metastatic Breast Cancer<\/strong><\/a>.<\/p>\n\n\n\n<p>The coveted status has been allocated to the <strong>HER2-targeting antibody-drug conjugate<\/strong> on the back of the <strong>DESTINY-Breast04 trial<\/strong> results, invented in <strong>February<\/strong>, which involved patients with <strong>HER2-low, unresectable, and metastatic breast cancer<\/strong> previously treated with 1-2 prior lines of chemotherapy.<\/p>\n\n\n\n<p>A breakthrough designation recognizes that a drug could offer a substantial improvement over available therapies for severe or life-threatening diseases. Drugs given the title are accelerated through the development process by the FDA, which can permit them a faster six-month review.<\/p>\n\n\n\n<p>The top-line results showed that Enhertu achieved a statistically significant and clinically meaningful improvement in both progression-free survival and overall survival compared to physicians&#8217; choice of chemotherapy.<\/p>\n\n\n\n<p>It was the first time that a HER2-directed therapy has shown a benefit in patients with <strong>HER2-low breast cancer<\/strong>, a group that accounts for around <strong>55%<\/strong> of all disease cases versus <strong>25%<\/strong> for <strong>HER2-positive tumors<\/strong>.<\/p>\n\n\n\n<p>Analysts at Credit Suisse added that expanding Enhertu&#8217;s use into HER2-low cancers could boost its sales by <strong>$3 billion<\/strong>. Last year, the sales were <strong>$426 million<\/strong>, more than double the amount made in the previous year, on expanded indications and more confidence among physicians in using the drug, which can have serious side effects.<\/p>\n\n\n\n<p><strong>Enhertu <\/strong>is approved as a <strong>third-line therapy<\/strong> for <strong>HER2-positive metastatic breast cancer<\/strong> and <strong>second-line <\/strong><a href=\"https:\/\/www.delveinsight.com\/report-store\/her2-positive-gastric-cancer-pipeline-insight\"><strong>treatment<\/strong> for <strong>HER2-positive metastatic gastric cancer<\/strong><\/a>.\u00a0<\/p>\n\n\n\n<p><strong>AstraZeneca<\/strong> and <strong>Daiichi Sankyo <\/strong>were previously awarded breakthrough designations for <strong>Enhertu <\/strong>as a treatment for <strong>second <\/strong>and <strong>later-line therapy of HER2-positive breast cancer<\/strong> and <strong>HER2-positive non-small cell lung cancer<\/strong> and <strong>gastric cancer<\/strong>.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"European_Commission_Approves_PfizerBiohaven_Migraine_Drug_Rimegepant\"><\/span><strong>European Commission Approves Pfizer\/Biohaven Migraine Drug Rimegepant<\/strong><span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p>In one of the regulatory updates, the <strong>Pfizer <\/strong>and <strong>Biohaven Pharmaceutical Holding Company<\/strong> announced that the European Commission (EC) has granted the marketing authorization for <strong>VYDURA\u00ae (rimegepant)<\/strong>. The EC decision follows the recommendation for approval by the European Medicines Agency&#8217;s Committee for Medicinal Products for Human Use in February.<\/p>\n\n\n\n<p><strong>VYDURA\u00ae <\/strong>is a calcitonin gene-related peptide (CGRP) receptor antagonist for both the <a href=\"https:\/\/www.delveinsight.com\/report-store\/migraine-market-insight\">acute treatment of migraine<\/a> with or without aura and prophylaxis of <a href=\"https:\/\/www.delveinsight.com\/report-store\/migraine-epidemiology-forecast\">episodic migraine in adults<\/a> who have at least four migraine attacks per month.&nbsp;<\/p>\n\n\n\n<p>VYDURA\u00ae is the first medicine approved for both <a href=\"https:\/\/www.delveinsight.com\/report-store\/migraine-pipeline-insight\">acute and prophylactic treatment of migraine<\/a> in the European Union (EU). The Phase 3 study published in Lancet has shown that rimegepant provided superior pain reduction and associated symptoms of migraine at two hours compared to a placebo. Further, the prevention study, also published in Lancet, exhibited that rimegepant taken every other day provided a superior reduction in the number of days per month with migraine in <strong>Weeks 9 \u201312<\/strong> of the 12-week treatment period compared to placebo,&nbsp;<\/p>\n\n\n\n<p>Earlier this year, Pfizer signed a collaboration and license agreement with Biohaven for the rights to market the migraine drugs outside of the US. According to the agreement, Biohaven will exclusively market Vydura in the US, while Pfizer would hold rights to commercialize the drug outside of the U.S, subject to regulatory approval.<\/p>\n\n\n\n<p>As per the DelveInsight, the most disabling disease among all diseases and the and the leading cause of disability among all neurological disorders. In Europe, <strong>one in ten people<\/strong> lives with the Migraine. Globally, migraine disproportionately affects women by three to four times compared to men.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"AstraZenecas_Ultomiris_Receives_its_Third_FDA_Approval\"><\/span><strong>AstraZeneca\u2019s Ultomiris Receives its Third FDA Approval<\/strong><span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p>AstraZeneca has announced FDA approval of its drug Ultomiris (ravulizumab-cwvz), a long-acting C5 complement inhibitor for the <a href=\"https:\/\/www.delveinsight.com\/report-store\/generalized-myasthenia-gravis-gmg-pipeline-insight\">treatment of adults with generalised myasthenia gravis (gMG)<\/a> who are anti-acetylcholine receptor (AChR) antibody-positive, which represents <strong>80%<\/strong> of people living with the disease. Ultomiris (ravulizumab-cwvz), the first and only long-acting C5 complement inhibitor, offers immediate, complete, and sustained complement inhibition and will benefit a broader range of patients, including those with milder symptoms.<\/p>\n\n\n\n<p>The Food and Drug Administration (FDA) has approved Ultomiris based on positive results from the CHAMPION-MG Phase III trial, in which ravulizumab-cwvz was superior to placebo in the primary endpoint of change from baseline in the Myasthenia Gravis-Activities of Daily Living Profile (MG-ADL) total score at Week 26.<\/p>\n\n\n\n<p>As per DelveInsight, Myasthenia gravis affects about 20 per 100,000 people worldwide. The prevalence has been increasing in recent decades, which likely results from earlier diagnosis and better treatments leading to longer lifespans for affected individuals. Generalized Myasthenia Gravis (gMG) is a more severe form of Myasthenia Gravis (MG) that may experience weakness in other muscle groups. gMG is a rare, debilitating, chronic, autoimmune neuromuscular disease that leads to a loss of muscle function and severe weakness. The <a href=\"https:\/\/www.delveinsight.com\/report-store\/myasthenia-gravis-market\">diagnosed prevalence of gMG<\/a> in the US is estimated at approximately 90,000. The approval of Ultomiris is expecte to improve the treatment scenario for the <a href=\"https:\/\/www.delveinsight.com\/report-store\/generalized-myasthenia-gravis-gmg-market\">patients affected with Generalized Myasthenia Gravis (gMG)<\/a>.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"FDA_Approves_Viloxazine_Capsules_for_Adults_with_ADHD\"><\/span><strong>FDA Approves Viloxazine Capsules for Adults with ADHD<\/strong><span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p><strong>Supernus Pharmaceuticals, Inc.<\/strong>, announced that the US Food and Drug Administration (FDA) has approved its <strong>viloxazine extended-release capsules (Qlebree)<\/strong> for the treatment of <a href=\"https:\/\/www.delveinsight.com\/report-store\/attention-deficit-hyperactivity-disorder-adhd-market\"><strong>Attention Deficit Hyperactivity Disorder (ADHD)<\/strong><\/a> in adult patients <strong>aged \u2265 18 years old<\/strong>, expanding the indicated ADHD patient age group for viloxazine to children \u22656 years old, adolescents and adults.&nbsp;<\/p>\n\n\n\n<p>Viloxazine extended-release capsules, available in doses ranging from <strong>200<\/strong> to <strong>600 mg<\/strong>, are recommended as a once-daily flexible-dose non-stimulant drug. Patients treated with <strong>Supernus <\/strong>achieved the primary endpoint of statistically significantly lower change from baseline in <strong>Adult ADHD Investigator Symptom Rating Scale (AISRS)<\/strong> total score versus placebo (<strong>P =.004<\/strong>) in the randomized, <strong>double-blind, placebo-controlled phase 3<\/strong> clinical trial data supporting Supernus&#8217; FDA application. AISRS subscale ratings for inattention and hyperactivity\/impulsivity symptoms improved significantly among treated individuals, according to the researchers. In addition, adult patients treated with viloxazine met the primary, secondary efficacy goal of change in the Clinical Global Impression \u2013 Severity of Illness scale from baseline to week 6 (<strong>P =.0023<\/strong>).<\/p>\n\n\n\n<p>Clinical trial data also indicate that the drug may cause manic or mixed episodes in people with <a href=\"https:\/\/www.delveinsight.com\/report-store\/bipolar-disorder-manic-depression-epidemiology-forecast\"><strong>Bipolar Disorder<\/strong><\/a>, and the label advises that patients be tested to see whether they are at risk for bipolar disorder. Regardless, the extended-release capsule is the first unique, non-stimulant alternative authorized for people with ADHD in over two decades. Greg Mattingly, MD, a founding partner of St. Charles Psychiatric Associates in St. Louis, emphasized the significance of the recent approval of the estimated <strong>10 million US<\/strong> adults who have treatable ADHD.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"FDA_Approves_Rinvoq_for_Adults_with_Ankylosing_Spondylitis\"><\/span><strong>FDA Approves Rinvoq for Adults with Ankylosing Spondylitis<\/strong><span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p>The FDA has authorized once-daily <strong>15 mg upadacitinib (RINVOQ)<\/strong> to treat people with <strong>Active <\/strong><a href=\"https:\/\/www.delveinsight.com\/report-store\/ankylosing-spondylitis-as-market\"><strong>Ankylosing Spondylitis<\/strong><\/a>. They have previously had an inadequate response or intolerance to <strong>1 tumor necrosis factor (TNF) inhibitor<\/strong>. The approval obtained by <strong>AbbVie <\/strong>adds the <strong>JAK inhibitor<\/strong> as a therapeutic option for active ankylosing spondylitis patients. It is the fifth FDA indication upadacitinib in treating <strong>chronic immune-mediated diseases<\/strong>. Ankylosing Spondylitis is a chronic inflammatory musculoskeletal disorder that predominantly affects the spine and causes painful symptoms such as inflammatory back pain, stiffness, and limited mobility. Ankylosing Spondylitis affects around one out of every 200 individuals in the United States, or approximately <strong>1.1 million<\/strong> people.<\/p>\n\n\n\n<p>Data from the <strong>SELECT-AXIS trial<\/strong>, a pair of pivotal <strong>phase 2\/3<\/strong> clinical studies. A significantly more significant proportion of patients receiving <strong>15 mg<\/strong> therapy accomplished composite assessment ankylosing spondylitis improvement of <strong>\u226540%<\/strong> (ASAS40) than patients receiving placebo at week 14, supported AbbVie&#8217;s application of upadacitinib. Adult patients with active ankylosing spondylitis who were naive to biologic disease-modifying antirheumatic drugs and had a poor response or intolerance to \u22652 nonsteroidal anti-inflammatory drugs were included in the experiment. ASAS40 rates in SELECT-AXIS 1 and 2 comprised <strong>51.0%<\/strong> and <strong>44.5%<\/strong> of patients on upadacitinib, respectively, against <strong>26.0%<\/strong> and <strong>18.2%<\/strong> of patients on placebo.<\/p>\n\n\n\n<p>Overall, the safety profile reported in individuals with active AS treated with <strong>RINVOQ 15 mg<\/strong> was consistent with that observed in <a href=\"https:\/\/www.delveinsight.com\/report-store\/rheumatoid-arthritis-ra-market\"><strong>Rheumatoid Arthritis<\/strong><\/a> and <a href=\"https:\/\/www.delveinsight.com\/report-store\/psoriatic-arthritis-market\"><strong>Psoriatic Arthritis<\/strong><\/a> patients. RINVOQ may cause serious side effects such as infections, cancer, immune system problems, an increased risk of major cardiovascular events, blood clots, allergic reactions, and tears in the stomach or intestines, among others.&nbsp;<\/p>\n\n\n\n<p>Nonetheless, since there are currently few treatment alternatives for individuals living with ankylosing spondylitis, with the recent FDA approval, patients now have an additional oral treatment option to help take control of this disease.<\/p>\n","protected":false},"excerpt":{"rendered":"<p>FDA Grants Fast Track Designation to VB-111 for Platinium-resistant Ovarian Cancer The FDA has given VBL Therapeutics\u2019 VB-111 (ofranergene obadenovec), a targeted anticancer viral gene therapy, fast track designation for use as a viable therapeutic option in patients with platinum-resistant Ovarian Cancer. VB-111 is intended to target a wide spectrum of solid tumors, including ovarian [&hellip;]<\/p>\n","protected":false},"author":6,"featured_media":17223,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"_editorskit_title_hidden":false,"_editorskit_reading_time":0,"_editorskit_is_block_options_detached":false,"_editorskit_block_options_position":"{}","advgb_blocks_editor_width":"","advgb_blocks_columns_visual_guide":"","footnotes":""},"categories":[32],"tags":[16250,19102,19300,19299,258,18983,19298,1193,18316,444],"industry":[17225],"therapeutic_areas":[17229,17227,17241,17245,17228,17234],"class_list":["post-17219","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-notizia","tag-adhd","tag-ankylosing-spondylitis","tag-attention-deficit-hyperactivity-disorder-3","tag-breast-cancers","tag-gene-therapy","tag-generalized-myasthenia-gravis","tag-metastatic-cervical-cancer","tag-migraine","tag-obstructive-hypertrophic-cardiomyopathy","tag-ovarian-cancer","industry-pharmaceutical","therapeutic_areas-central-nervous-system","therapeutic_areas-immunological-and-autoimmune-disorders","therapeutic_areas-musculoskeletal","therapeutic_areas-neurology","therapeutic_areas-oncology","therapeutic_areas-rare-diseases"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO Premium plugin v25.8 (Yoast SEO v25.8) - https:\/\/yoast.com\/wordpress\/plugins\/seo\/ -->\n<title>Pharma News and Updates | AstraZeneca, Supernus, BMS, Merck, Pfizer<\/title>\n<meta name=\"description\" content=\"VBL\u2019s VB-111 (ofranergene obadenovec); BMS\u2019s mavacamten (Camzyos); Merck\u2019s KEYTRUDA; Pfizer\/Biohaven\u2019s VYDURA (rimegepant); AZ&#039;s Ultomiris\" \/>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/www.delveinsight.com\/blog\/pharma-news-for-astrazeneca-bms-merck\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Pharma News and Updates | AstraZeneca, Supernus, BMS, Merck, Pfizer\" \/>\n<meta property=\"og:description\" content=\"VBL\u2019s VB-111 (ofranergene obadenovec); BMS\u2019s mavacamten (Camzyos); Merck\u2019s KEYTRUDA; Pfizer\/Biohaven\u2019s VYDURA (rimegepant); AZ&#039;s Ultomiris\" \/>\n<meta property=\"og:url\" content=\"https:\/\/www.delveinsight.com\/blog\/pharma-news-for-astrazeneca-bms-merck\" \/>\n<meta property=\"og:site_name\" content=\"DelveInsight Business Research\" \/>\n<meta property=\"article:publisher\" content=\"https:\/\/www.facebook.com\/DelveInsight-1423323754607782\/\" \/>\n<meta property=\"article:published_time\" content=\"2022-05-03T08:27:26+00:00\" \/>\n<meta property=\"article:modified_time\" content=\"2022-06-14T03:55:58+00:00\" \/>\n<meta property=\"og:image\" content=\"https:\/\/assets.delveinsight.com\/blog\/wp-content\/uploads\/2022\/05\/03135615\/Pharma-News-and-Updates-for-AstraZeneca-Supernus-and-BMS.png\" \/>\n\t<meta property=\"og:image:width\" content=\"772\" \/>\n\t<meta property=\"og:image:height\" content=\"482\" \/>\n\t<meta property=\"og:image:type\" content=\"image\/png\" \/>\n<meta name=\"author\" content=\"DelveInsight\" \/>\n<meta name=\"twitter:card\" content=\"summary_large_image\" \/>\n<meta name=\"twitter:creator\" content=\"@DelveInsight\" \/>\n<meta name=\"twitter:site\" content=\"@DelveInsight\" \/>\n<meta name=\"twitter:label1\" content=\"Written by\" \/>\n\t<meta name=\"twitter:data1\" content=\"DelveInsight\" \/>\n\t<meta name=\"twitter:label2\" content=\"Est. reading time\" \/>\n\t<meta name=\"twitter:data2\" content=\"10 minutes\" \/>\n<!-- \/ Yoast SEO Premium plugin. -->","yoast_head_json":{"title":"Pharma News and Updates | AstraZeneca, Supernus, BMS, Merck, Pfizer","description":"VBL\u2019s VB-111 (ofranergene obadenovec); BMS\u2019s mavacamten (Camzyos); Merck\u2019s KEYTRUDA; Pfizer\/Biohaven\u2019s VYDURA (rimegepant); AZ's Ultomiris","robots":{"index":"index","follow":"follow","max-snippet":"max-snippet:-1","max-image-preview":"max-image-preview:large","max-video-preview":"max-video-preview:-1"},"canonical":"https:\/\/www.delveinsight.com\/blog\/pharma-news-for-astrazeneca-bms-merck","og_locale":"en_US","og_type":"article","og_title":"Pharma News and Updates | AstraZeneca, Supernus, BMS, Merck, Pfizer","og_description":"VBL\u2019s VB-111 (ofranergene obadenovec); BMS\u2019s mavacamten (Camzyos); Merck\u2019s KEYTRUDA; Pfizer\/Biohaven\u2019s VYDURA (rimegepant); AZ's Ultomiris","og_url":"https:\/\/www.delveinsight.com\/blog\/pharma-news-for-astrazeneca-bms-merck","og_site_name":"DelveInsight Business Research","article_publisher":"https:\/\/www.facebook.com\/DelveInsight-1423323754607782\/","article_published_time":"2022-05-03T08:27:26+00:00","article_modified_time":"2022-06-14T03:55:58+00:00","og_image":[{"width":772,"height":482,"url":"https:\/\/assets.delveinsight.com\/blog\/wp-content\/uploads\/2022\/05\/03135615\/Pharma-News-and-Updates-for-AstraZeneca-Supernus-and-BMS.png","type":"image\/png"}],"author":"DelveInsight","twitter_card":"summary_large_image","twitter_creator":"@DelveInsight","twitter_site":"@DelveInsight","twitter_misc":{"Written by":"DelveInsight","Est. reading time":"10 minutes"},"schema":{"@context":"https:\/\/schema.org","@graph":[{"@type":"WebPage","@id":"https:\/\/www.delveinsight.com\/blog\/pharma-news-for-astrazeneca-bms-merck","url":"https:\/\/www.delveinsight.com\/blog\/pharma-news-for-astrazeneca-bms-merck","name":"Pharma News and Updates | AstraZeneca, Supernus, BMS, Merck, Pfizer","isPartOf":{"@id":"https:\/\/www.delveinsight.com\/blog\/#website"},"primaryImageOfPage":{"@id":"https:\/\/www.delveinsight.com\/blog\/pharma-news-for-astrazeneca-bms-merck#primaryimage"},"image":{"@id":"https:\/\/www.delveinsight.com\/blog\/pharma-news-for-astrazeneca-bms-merck#primaryimage"},"thumbnailUrl":"https:\/\/assets.delveinsight.com\/blog\/wp-content\/uploads\/2022\/05\/03135615\/Pharma-News-and-Updates-for-AstraZeneca-Supernus-and-BMS.png","datePublished":"2022-05-03T08:27:26+00:00","dateModified":"2022-06-14T03:55:58+00:00","author":{"@id":"https:\/\/www.delveinsight.com\/blog\/#\/schema\/person\/0d96a31a370c143ffdb481d985d7edfd"},"description":"VBL\u2019s VB-111 (ofranergene obadenovec); BMS\u2019s mavacamten (Camzyos); Merck\u2019s KEYTRUDA; Pfizer\/Biohaven\u2019s VYDURA (rimegepant); AZ's Ultomiris","inLanguage":"en-US","potentialAction":[{"@type":"ReadAction","target":["https:\/\/www.delveinsight.com\/blog\/pharma-news-for-astrazeneca-bms-merck"]}]},{"@type":"ImageObject","inLanguage":"en-US","@id":"https:\/\/www.delveinsight.com\/blog\/pharma-news-for-astrazeneca-bms-merck#primaryimage","url":"https:\/\/assets.delveinsight.com\/blog\/wp-content\/uploads\/2022\/05\/03135615\/Pharma-News-and-Updates-for-AstraZeneca-Supernus-and-BMS.png","contentUrl":"https:\/\/assets.delveinsight.com\/blog\/wp-content\/uploads\/2022\/05\/03135615\/Pharma-News-and-Updates-for-AstraZeneca-Supernus-and-BMS.png","width":772,"height":482,"caption":"Pharma News and Updates for AstraZeneca, Supernus, and BMS"},{"@type":"WebSite","@id":"https:\/\/www.delveinsight.com\/blog\/#website","url":"https:\/\/www.delveinsight.com\/blog\/","name":"DelveInsight Business Research","description":"Blog","potentialAction":[{"@type":"SearchAction","target":{"@type":"EntryPoint","urlTemplate":"https:\/\/www.delveinsight.com\/blog\/?s={search_term_string}"},"query-input":{"@type":"PropertyValueSpecification","valueRequired":true,"valueName":"search_term_string"}}],"inLanguage":"en-US"},{"@type":"Person","@id":"https:\/\/www.delveinsight.com\/blog\/#\/schema\/person\/0d96a31a370c143ffdb481d985d7edfd","name":"DelveInsight","image":{"@type":"ImageObject","inLanguage":"en-US","@id":"https:\/\/www.delveinsight.com\/blog\/#\/schema\/person\/image\/","url":"https:\/\/secure.gravatar.com\/avatar\/f9314f22b8c5b61d496451e91f32488d2457ecb59283b7b2ad7e82d330b47aba?s=96&d=mm&r=g","contentUrl":"https:\/\/secure.gravatar.com\/avatar\/f9314f22b8c5b61d496451e91f32488d2457ecb59283b7b2ad7e82d330b47aba?s=96&d=mm&r=g","caption":"DelveInsight"}}]}},"author_meta":{"display_name":"DelveInsight","author_link":"https:\/\/www.delveinsight.com\/blog\/author\/arawat"},"featured_img":"https:\/\/assets.delveinsight.com\/blog\/wp-content\/uploads\/2022\/05\/03135615\/Pharma-News-and-Updates-for-AstraZeneca-Supernus-and-BMS-300x187.png","coauthors":[],"tax_additional":{"categories":{"linked":["<a href=\"https:\/\/www.delveinsight.com\/blog\/notizia\/\" class=\"advgb-post-tax-term\">Notizia - Recent Pharma, Healthcare and Biotech Happenings<\/a>"],"unlinked":["<span class=\"advgb-post-tax-term\">Notizia - Recent Pharma, Healthcare and Biotech Happenings<\/span>"]},"tags":{"linked":["<a href=\"https:\/\/www.delveinsight.com\/blog\/notizia\/\" class=\"advgb-post-tax-term\">ADHD<\/a>","<a href=\"https:\/\/www.delveinsight.com\/blog\/notizia\/\" class=\"advgb-post-tax-term\">Ankylosing Spondylitis<\/a>","<a href=\"https:\/\/www.delveinsight.com\/blog\/notizia\/\" class=\"advgb-post-tax-term\">Attention-deficit\/hyperactivity disorder<\/a>","<a href=\"https:\/\/www.delveinsight.com\/blog\/notizia\/\" class=\"advgb-post-tax-term\">breast cancers<\/a>","<a href=\"https:\/\/www.delveinsight.com\/blog\/notizia\/\" class=\"advgb-post-tax-term\">Gene therapy<\/a>","<a href=\"https:\/\/www.delveinsight.com\/blog\/notizia\/\" class=\"advgb-post-tax-term\">Generalized Myasthenia Gravis<\/a>","<a href=\"https:\/\/www.delveinsight.com\/blog\/notizia\/\" class=\"advgb-post-tax-term\">Metastatic Cervical Cancer<\/a>","<a href=\"https:\/\/www.delveinsight.com\/blog\/notizia\/\" class=\"advgb-post-tax-term\">Migraine<\/a>","<a href=\"https:\/\/www.delveinsight.com\/blog\/notizia\/\" class=\"advgb-post-tax-term\">Obstructive Hypertrophic Cardiomyopathy<\/a>","<a href=\"https:\/\/www.delveinsight.com\/blog\/notizia\/\" class=\"advgb-post-tax-term\">Ovarian Cancer<\/a>"],"unlinked":["<span class=\"advgb-post-tax-term\">ADHD<\/span>","<span class=\"advgb-post-tax-term\">Ankylosing Spondylitis<\/span>","<span class=\"advgb-post-tax-term\">Attention-deficit\/hyperactivity disorder<\/span>","<span class=\"advgb-post-tax-term\">breast cancers<\/span>","<span class=\"advgb-post-tax-term\">Gene therapy<\/span>","<span class=\"advgb-post-tax-term\">Generalized Myasthenia Gravis<\/span>","<span class=\"advgb-post-tax-term\">Metastatic Cervical Cancer<\/span>","<span class=\"advgb-post-tax-term\">Migraine<\/span>","<span class=\"advgb-post-tax-term\">Obstructive Hypertrophic Cardiomyopathy<\/span>","<span class=\"advgb-post-tax-term\">Ovarian Cancer<\/span>"]}},"comment_count":"0","relative_dates":{"created":"Posted 4 years ago","modified":"Updated 4 years ago"},"absolute_dates":{"created":"Posted on May 3, 2022","modified":"Updated on Jun 14, 2022"},"absolute_dates_time":{"created":"Posted on May 3, 2022 1:57 pm","modified":"Updated on Jun 14, 2022 9:25 am"},"featured_img_caption":"Pharma News and Updates for AstraZeneca, Supernus, and BMS","series_order":"","_links":{"self":[{"href":"https:\/\/www.delveinsight.com\/blog\/wp-json\/wp\/v2\/posts\/17219","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.delveinsight.com\/blog\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/www.delveinsight.com\/blog\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/www.delveinsight.com\/blog\/wp-json\/wp\/v2\/users\/6"}],"replies":[{"embeddable":true,"href":"https:\/\/www.delveinsight.com\/blog\/wp-json\/wp\/v2\/comments?post=17219"}],"version-history":[{"count":0,"href":"https:\/\/www.delveinsight.com\/blog\/wp-json\/wp\/v2\/posts\/17219\/revisions"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/www.delveinsight.com\/blog\/wp-json\/wp\/v2\/media\/17223"}],"wp:attachment":[{"href":"https:\/\/www.delveinsight.com\/blog\/wp-json\/wp\/v2\/media?parent=17219"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.delveinsight.com\/blog\/wp-json\/wp\/v2\/categories?post=17219"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.delveinsight.com\/blog\/wp-json\/wp\/v2\/tags?post=17219"},{"taxonomy":"industry","embeddable":true,"href":"https:\/\/www.delveinsight.com\/blog\/wp-json\/wp\/v2\/industry?post=17219"},{"taxonomy":"therapeutic_areas","embeddable":true,"href":"https:\/\/www.delveinsight.com\/blog\/wp-json\/wp\/v2\/therapeutic_areas?post=17219"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}