{"id":28535,"date":"2024-07-02T12:48:46","date_gmt":"2024-07-02T07:18:46","guid":{"rendered":"https:\/\/www.delveinsight.com\/blog\/?p=28535"},"modified":"2024-07-02T12:48:50","modified_gmt":"2024-07-02T07:18:50","slug":"pharma-news-for-eisai-merck-verona-astrazeneca","status":"publish","type":"post","link":"https:\/\/www.delveinsight.com\/blog\/pharma-news-for-eisai-merck-verona-astrazeneca","title":{"rendered":"Eisai Announces Solo Development of Farletuzumab Ecteribulin (FZEC); Johnson &amp; Johnson\u2019s Nipocalimab Phase III Trial; Merck\u2019s WINREVAIR\u00a0 EU CHMP Recommendation;\u00a0 Verona Pharma\u2019s\u00a0 Ohtuvayre FDA Approval; AstraZeneca\u2019s Lynparza and Imfinzi EU Approval"},"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-69f297460aa66\" 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-69f297460aa66\"  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-eisai-merck-verona-astrazeneca\/#Eisai_Announces_Solo_Venture_for_Farletuzumab_Ecteribulin_FZEC_Antibody_Drug_Conjugate\" >Eisai Announces Solo Venture for Farletuzumab Ecteribulin (FZEC) Antibody Drug Conjugate<\/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-eisai-merck-verona-astrazeneca\/#Nipocalimab_Phase_III_Trial_Shows_Unprecedented_Long-Term_Disease_Control_in_FcRn_Class\" >Nipocalimab Phase III Trial Shows Unprecedented Long-Term Disease Control in FcRn Class<\/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-eisai-merck-verona-astrazeneca\/#Merck_Gains_Favorable_EU_CHMP_Recommendation_for_WINREVAIR_in_Treating_Pulmonary_Arterial_Hypertension\" >Merck Gains Favorable EU CHMP Recommendation for WINREVAIR in Treating Pulmonary Arterial Hypertension<\/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-eisai-merck-verona-astrazeneca\/#Verona_Pharma_Gains_FDA_Approval_for_Ohtuvayre\" >Verona Pharma Gains FDA Approval for Ohtuvayre<\/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-eisai-merck-verona-astrazeneca\/#CHMP_Recommends_EU_Approval_for_Combination_of_Lynparza_and_Imfinzi_in_Treating_Mismatch_Repair_Proficient_Advanced_or_Recurrent_Endometrial_Cancer\" >CHMP Recommends EU Approval for Combination of Lynparza and Imfinzi in Treating Mismatch Repair Proficient Advanced or Recurrent Endometrial Cancer<\/a><\/li><\/ul><\/nav><\/div>\n\n<h2 class=\"wp-block-heading\" id=\"h-eisai-announces-solo-venture-for-farletuzumab-ecteribulin-fzec-antibody-drug-conjugate\"><span class=\"ez-toc-section\" id=\"Eisai_Announces_Solo_Venture_for_Farletuzumab_Ecteribulin_FZEC_Antibody_Drug_Conjugate\"><\/span>Eisai Announces Solo Venture for Farletuzumab Ecteribulin (FZEC) Antibody Drug Conjugate<span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p><strong>Eisai Co., Ltd.<\/strong> announced the termination of its global strategic collaboration with <strong>Bristol Myers Squibb <\/strong>for the co-development and co-commercialization of <strong>farletuzumab ecteribulin (FZEC)<\/strong>, previously known as MORAb-202, an <a href=\"https:\/\/www.delveinsight.com\/report-store\/antibody-drug-conjugate-market\">antibody-drug conjugate (ADC)<\/a> targeting the folate receptor alpha (FR\u03b1). This decision is due to Bristol Myers Squibb&#8217;s ongoing portfolio prioritization efforts. As a result, Eisai now holds all rights to FZEC and will independently handle its global development and commercialization. Eisai is prioritizing the development of FZEC to make it available to patients as soon as possible. Additionally, Eisai intends to refund a portion of the unused <strong>$200 million<\/strong> payment it received for research and development expenses from Bristol Myers Squibb and will record the remaining amount as other income.<\/p>\n\n\n\n<p>FZEC is Eisai&#8217;s first ADC, developed from the company&#8217;s internally developed farletuzumab, a humanized IgG1 monoclonal antibody targeting FR\u03b1, and the anticancer agent eribulin, linked via an enzymatically cleavable linker. Presently, three clinical trials are in progress: Eisai\u2019s Phase I\/II study for solid tumors (NCT04300556), and Bristol Myers Squibb\u2019s Phase II studies for ovarian, peritoneal, and fallopian tube cancers (NCT05613088), as well as non-small cell lung cancer.<\/p>\n\n\n\n<p>Eisai focuses on oncology as a major area and strives to contribute to cancer cures by delving deeply into human biology. The development of FZEC for treatment-resistant cancers demonstrates our commitment to meeting the unmet needs of cancer patients. Eisai will persist in its efforts to enhance the benefits for patients with cancer and their families.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-nipocalimab-phase-iii-trial-shows-unprecedented-long-term-disease-control-in-fcrn-class\"><span class=\"ez-toc-section\" id=\"Nipocalimab_Phase_III_Trial_Shows_Unprecedented_Long-Term_Disease_Control_in_FcRn_Class\"><\/span>Nipocalimab Phase III Trial Shows Unprecedented Long-Term Disease Control in FcRn Class<span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p><strong>Johnson &amp; Johnson <\/strong>reported favorable outcomes from the <strong>nipocalimab Phase III Vivacity-MG3 study<\/strong> for patients with generalized myasthenia gravis (gMG). Those receiving nipocalimab combined with standard care (SOC) outperformed the placebo group, as indicated by the primary endpoint of improvement in the MG-ADL score over 24 weeks. These findings are part of a presentation and are among eight abstracts that Johnson &amp; Johnson will present at the <strong>2024 European Academy of Neurology (EAN) Congress<\/strong>. They will also be included in submissions to regulatory authorities later this year.<\/p>\n\n\n\n<blockquote class=\"wp-block-quote is-layout-flow wp-block-quote-is-layout-flow\">\n<p><em>&#8220;The prolonged effectiveness of nipocalimab over six months in a diverse myasthenia gravis population is a significant discovery, considering the chronic and unpredictable flare-ups common with this condition,\u201d stated Carlo Antozzi, M.D., from the Neuroimmunology and Muscle Pathology Unit at the Neurological Institute Foundation C. Besta in Milan, Italy. \u201cWe are optimistic about nipocalimab&#8217;s potential to uniquely address the needs of individuals with myasthenia gravis.\u201d<\/em><\/p>\n<\/blockquote>\n\n\n\n<p>The study, conducted under double-blind placebo-controlled conditions, included a diverse group of patients who tested positive for anti-AChR, anti-MuSK, and\/or anti-LRP4 antibodies, encompassing around 95 percent of the gMG patient population.2 Participants treated with nipocalimab in addition to standard of care (SOC) showed a significant improvement of 4.70 points on the MG-ADL scale, compared to a 3.25 point improvement observed in those receiving placebo alongside SOC over Weeks 22, 23, and 24 (P=0.002)c. For <a href=\"https:\/\/www.delveinsight.com\/report-store\/generalized-myasthenia-gravis-gmg-market\">individuals living with gMG<\/a>, a change of 1 to 2 points on the MG-ADL scale could mean the difference between normal eating and experiencing frequent choking, or between experiencing shortness of breath at rest and requiring a ventilator.<\/p>\n\n\n\n<p>Safety and tolerability were in line with findings from previous nipocalimab investigations. The overall occurrence of adverse events, serious adverse events, and events causing discontinuation was comparable to those observed in the placebo plus standard-of-care group.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-merck-gains-favorable-eu-chmp-recommendation-for-winrevair-in-treating-pulmonary-arterial-hypertension\"><span class=\"ez-toc-section\" id=\"Merck_Gains_Favorable_EU_CHMP_Recommendation_for_WINREVAIR_in_Treating_Pulmonary_Arterial_Hypertension\"><\/span>Merck Gains Favorable EU CHMP Recommendation for WINREVAIR in Treating Pulmonary Arterial Hypertension<span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p><strong>Merck <\/strong>has announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended the approval of <strong>WINREVAIR\u2122 (sotatercept)<\/strong>, alongside other <a href=\"https:\/\/www.delveinsight.com\/report-store\/pulmonary-arterial-hypertension-market\">therapies for pulmonary arterial hypertension<\/a>, for treating PAH in adults with World Health Organization (WHO) Functional Class (FC) II to III to enhance exercise capacity. WINREVAIR previously received Priority Medicines (PRIME) and orphan designation from the EMA for PAH treatment. The European Commission (EC) will now evaluate the CHMP&#8217;s recommendation, with a decision on WINREVAIR&#8217;s marketing authorization application in the EU, Iceland, Liechtenstein, and Norway expected in the third quarter of 2024.<\/p>\n\n\n\n<p>WINREVAIR is given once every three weeks as a single injection under the skin and can be administered by patients or caregivers under the guidance, training, and follow-up of a healthcare provider.<\/p>\n\n\n\n<p>The CHMP&#8217;s recommendation stems from data from the Phase III STELLAR trial of WINREVAIR in addition to background PAH therapy, compared to therapy alone. WINREVAIR showed a statistically significant and clinically meaningful enhancement in the 6-minute walk distance, which was the primary endpoint of the study. It also demonstrated improvements in several important secondary outcomes, including a decrease in the risk of death from any cause or PAH clinical worsening events. These findings were published in The New England Journal of Medicine.<\/p>\n\n\n\n<p>The EMA&#8217;s CHMP recommendation marks the second regulatory endorsement of WINREVAIR for treating PAH, following a thorough assessment of crucial efficacy and safety data. <a href=\"https:\/\/www.delveinsight.com\/blog\/winrevair-for-pulmonary-arterial-hypertension-treatment\">WINREVAIR (sotatercept-csrk)<\/a> received FDA approval in March 2024.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-verona-pharma-gains-fda-approval-for-ohtuvayre\"><span class=\"ez-toc-section\" id=\"Verona_Pharma_Gains_FDA_Approval_for_Ohtuvayre\"><\/span>Verona Pharma Gains FDA Approval for Ohtuvayre<span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p><strong>Verona Pharma plc<\/strong> has reported that the FDA has approved <strong>Ohtuvayre (ensifentrine)<\/strong> for the ongoing treatment of chronic obstructive pulmonary disease (COPD) in adults. Ohtuvayre represents the first inhaled product with a new mechanism of action to be offered for the maintenance <a href=\"https:\/\/www.delveinsight.com\/report-store\/chronic-obstructive-pulmonary-disease-copd-market\">treatment of COPD<\/a> in over two decades.<\/p>\n\n\n\n<p>Ohtuvayre represents a novel selective dual inhibitor targeting both phosphodiesterase 3 and phosphodiesterase 4 enzymes (&#8220;PDE3 and PDE4&#8221;). This compound combines bronchodilator and non-steroidal anti-inflammatory properties within a single molecule. It is administered directly to the lungs using a standard jet nebulizer, eliminating the requirement for high inspiratory flow rates or complicated hand-breath coordination.<\/p>\n\n\n\n<blockquote class=\"wp-block-quote is-layout-flow wp-block-quote-is-layout-flow\">\n<p><em>David Zaccardelli, Pharm. D., President and CEO of Verona Pharma, described the approval of Ohtuvayre as a major step forward in COPD treatment, suggesting that its unique characteristics could revolutionize how COPD is managed. He indicated plans to introduce Ohtuvayre to the market in the third quarter of 2024, aiming to provide relief for the millions of COPD patients who continue to suffer from daily symptoms.<\/em><\/p>\n<\/blockquote>\n\n\n\n<p>The US approval of Ohtuvayre relied on comprehensive data from the <strong>Phase III ENHANCE trials<\/strong>, whose outcomes were detailed in the American Journal of Respiratory and Critical Care Medicine. These trials showed that Ohtuvayre provided clinical advantages when used alone or in combination with other maintenance <a href=\"https:\/\/www.delveinsight.com\/report-store\/chronic-obstructive-pulmonary-disease-copd-market\">treatments for moderate to severe COPD patients<\/a>. The medication demonstrated good tolerability across a diverse range of subjects.<\/p>\n\n\n\n<p>The Company is fully prepared for the launch and anticipates Ohtuvayre to be accessible starting in the third quarter of 2024 through a dedicated network of accredited specialty pharmacies.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-chmp-recommends-eu-approval-for-combination-of-lynparza-and-imfinzi-in-treating-mismatch-repair-proficient-advanced-or-recurrent-endometrial-cancer\"><span class=\"ez-toc-section\" id=\"CHMP_Recommends_EU_Approval_for_Combination_of_Lynparza_and_Imfinzi_in_Treating_Mismatch_Repair_Proficient_Advanced_or_Recurrent_Endometrial_Cancer\"><\/span>CHMP Recommends EU Approval for Combination of Lynparza and Imfinzi in Treating Mismatch Repair Proficient Advanced or Recurrent Endometrial Cancer<span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p><strong>AstraZeneca&#8217;s drugs Imfinzi (durvalumab) and Lynparza (olaparib)<\/strong> have received approval recommendations in the European Union for treating specific groups of <a href=\"https:\/\/www.delveinsight.com\/report-store\/endometrial-cancer-market\">patients with primary advanced or recurrent endometrial cancer<\/a>. For patients with mismatch repair proficient (pMMR) disease, the recommendation includes using Imfinzi alongside chemotherapy as first-line treatment, followed by a combination of Lynparza and Imfinzi. For those with mismatch repair deficient (dMMR) disease, the recommendation involves Imfinzi plus chemotherapy followed by continued treatment with Imfinzi alone.<\/p>\n\n\n\n<p>The CHMP of the EMA based its favorable assessment on a specified exploratory subgroup analysis of mismatch repair (MMR) status from the <strong>DUO-E Phase III trial<\/strong>, published in the Journal of Clinical Oncology in October 2023.<\/p>\n\n\n\n<p>According to this analysis, pMMR patients in the Lynparza and Imfinzi group showed a 43% reduction in the risk of disease progression or death compared to the control group (median 15.0 months versus 9.7 months, hazard ratio [HR] 0.57; 95% confidence interval [CI] 0.44-0.73). For dMMR patients, results indicated a 58% reduction in the risk of disease progression or death in the Imfinzi group compared to the control group (median not reached versus 7.0 months, HR 0.42; 95% CI 0.22-0.80).<\/p>\n\n\n\n<blockquote class=\"wp-block-quote is-layout-flow wp-block-quote-is-layout-flow\">\n<p><em>Susan Galbraith, Executive Vice President of Oncology Research and Development at AstraZeneca, expressed that the EU&#8217;s recommendation for approval acknowledges the potential of combining Lynparza and Imfinzi to benefit patients with endometrial cancer, particularly those with mismatch repair proficient disease who currently have limited treatment options. She highlighted that if approved, this combination treatment would offer European patients a new therapeutic choice that combines PARP inhibition with immunotherapy, potentially enhancing clinical outcomes.<\/em><\/p>\n<\/blockquote>\n\n\n\n<p>The safety profiles of both new treatment plans were acceptable, well-received, and generally in line with the established profiles of the individual drugs. Regulatory authorities are currently reviewing submissions for Imfinzi and Lynparza in Japan and other countries, following the results of the DUO-E trial. In the US, Imfinzi combined with chemotherapy has recently gained approval for patients with primary advanced or recurrent endometrial cancer who have dMMR status.<\/p>\n","protected":false},"excerpt":{"rendered":"<p>Eisai Announces Solo Venture for Farletuzumab Ecteribulin (FZEC) Antibody Drug Conjugate Eisai Co., Ltd. announced the termination of its global strategic collaboration with Bristol Myers Squibb for the co-development and co-commercialization of farletuzumab ecteribulin (FZEC), previously known as MORAb-202, an antibody-drug conjugate (ADC) targeting the folate receptor alpha (FR\u03b1). This decision is due to Bristol [&hellip;]<\/p>\n","protected":false},"author":14,"featured_media":28536,"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":[77,719,718,20331,704,18983,349,420,639,499,5789,22149],"industry":[17225],"therapeutic_areas":[17242,17227,17228],"class_list":["post-28535","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-notizia","tag-antibody-drug-conjugate","tag-chronic-obstructive-pulmonary-disease","tag-copd","tag-endometrial-cancer","tag-fda","tag-generalized-myasthenia-gravis","tag-latest-pharma-news","tag-news","tag-pharma-news","tag-pulmonary-arterial-hypertension","tag-recent-pharma-news","tag-winrevair","industry-pharmaceutical","therapeutic_areas-cardiovascular-diseases","therapeutic_areas-immunological-and-autoimmune-disorders","therapeutic_areas-oncology"],"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 | Eisai, Merck, Verona Pharma, AstraZeneca<\/title>\n<meta name=\"description\" content=\"Eisai\u2019s Farletuzumab Ecteribulin; Johnson &amp; Johnson\u2019s Nipocalimab; Merck\u2019s WINREVAIR; Verona Pharma\u2019s Ohtuvayre\" \/>\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-eisai-merck-verona-astrazeneca\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Pharma News | Eisai, Merck, Verona Pharma, AstraZeneca\" \/>\n<meta property=\"og:description\" content=\"Eisai\u2019s Farletuzumab Ecteribulin; Johnson &amp; Johnson\u2019s Nipocalimab; Merck\u2019s WINREVAIR; Verona Pharma\u2019s 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