{"id":30295,"date":"2024-11-12T16:49:55","date_gmt":"2024-11-12T11:19:55","guid":{"rendered":"https:\/\/www.delveinsight.com\/blog\/?p=30295"},"modified":"2024-11-12T16:49:56","modified_gmt":"2024-11-12T11:19:56","slug":"pharma-news-for-autolus-unicycive-abbvie","status":"publish","type":"post","link":"https:\/\/www.delveinsight.com\/blog\/pharma-news-for-autolus-unicycive-abbvie","title":{"rendered":"AUCATZYL Approved for R\/R B-ALL; FDA Accepts NDA for Unicycive\u2019s Oxylanthanum Carbonate; AstraZeneca and Amgen Report Positive Results in Chronic Rhinosinusitis; Nipocalimab Granted Breakthrough Designation for Sj\u00f6gren\u2019s Disease; AbbVie\u2019s Schizophrenia Drug Fails Phase Studies"},"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-69f80528d615f\" 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-69f80528d615f\"  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-autolus-unicycive-abbvie\/#FDA_Approves_Autoluss_AUCATZYL_for_RelapsedRefractory_B-cell_Acute_Lymphoblastic_Leukemia\" >FDA Approves Autolus&#8217;s AUCATZYL for Relapsed\/Refractory B-cell Acute Lymphoblastic Leukemia<\/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-autolus-unicycive-abbvie\/#Unicycives_Oxylanthanum_Carbonate_NDA_Accepted_by_FDA_for_Hyperphosphatemia_in_Dialysis_Patients\" >Unicycive&#8217;s Oxylanthanum Carbonate NDA Accepted by FDA for Hyperphosphatemia in Dialysis Patients<\/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-autolus-unicycive-abbvie\/#AstraZenecaAmgen_Report_Positive_Chronic_Rhinosinusitis_Trial_Results_But_Face_Regulatory_Hurdles\" >AstraZeneca\/Amgen Report Positive Chronic Rhinosinusitis Trial Results, But Face Regulatory Hurdles<\/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-autolus-unicycive-abbvie\/#Nipocalimab_Receives_FDA_Breakthrough_Therapy_Designation_for_Moderate-to-Severe_Sjogrens_Disease\" >Nipocalimab Receives FDA Breakthrough Therapy Designation for Moderate-to-Severe Sj\u00f6gren\u2019s Disease<\/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-autolus-unicycive-abbvie\/#AbbVies_Schizophrenia_Drug_Fails_in_Two_Studies\" >AbbVie\u2019s Schizophrenia Drug Fails in Two Studies<\/a><\/li><\/ul><\/nav><\/div>\n\n<h2 class=\"wp-block-heading\" id=\"h-fda-approves-autolus-s-aucatzyl-for-relapsed-refractory-b-cell-acute-lymphoblastic-leukemia\"><span class=\"ez-toc-section\" id=\"FDA_Approves_Autoluss_AUCATZYL_for_RelapsedRefractory_B-cell_Acute_Lymphoblastic_Leukemia\"><\/span>FDA Approves Autolus&#8217;s AUCATZYL for Relapsed\/Refractory B-cell Acute Lymphoblastic Leukemia<span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p>Autolus Therapeutics has achieved a significant milestone with FDA approval for AUCATZYL (obecabtagene autoleucel), a next-generation <a href=\"https:\/\/www.delveinsight.com\/report-store\/car-t-cell-therapy-for-acute-lymphoblastic-leukemia-market\" class=\"ek-link\">CAR T-cell therapy for adults with relapsed or refractory B-cell acute lymphoblastic leukemia (R\/R B-ALL)<\/a>. This approval, granted based on results from the FELIX clinical trial, highlights the therapy&#8217;s efficacy, with a 63% overall complete remission rate in the efficacy-evaluable patient cohort. Notably, AUCATZYL also demonstrated a favorable safety profile with low rates of severe <a href=\"https:\/\/www.delveinsight.com\/report-store\/cytokine-release-syndrome-market\">Cytokine Release Syndrome <\/a>and Immune Effector Cell-Associated Neurotoxicity Syndrome (ICANS), without requiring a Risk Evaluation and Mitigation Strategy (REMS).<\/p>\n\n\n\n<p>In addition to its U.S. approval, Autolus has expanded its manufacturing capabilities to meet demand, establishing the Nucleus facility in Stevenage, UK. This facility has received certifications from both the MHRA and the FDA, allowing it to support the global distribution of AUCATZYL. Autolus has now begun collaborating with U.S. treatment centers to make AUCATZYL available to eligible patients and is actively seeking additional approvals in the EU and UK.<\/p>\n\n\n\n<blockquote class=\"wp-block-quote is-layout-flow wp-block-quote-is-layout-flow\">\n<p><em>&#8220;Adult ALL is an extremely aggressive cancer, and there is a high unmet medical need for these patients once they relapse,&#8221; said Dr. Elias Jabbour, U.S. lead investigator of the FELIX study and professor at MD Anderson Cancer Center. &#8220;This milestone approval, based on the demonstrated clinical benefit of AUCATZYL, brings new hope for adult patients with relapsed\/refractory B-ALL.&#8221;<\/em><\/p>\n<\/blockquote>\n\n\n\n<blockquote class=\"wp-block-quote is-layout-flow wp-block-quote-is-layout-flow\">\n<p><em>Dr. Claire Roddie, Associate Professor at University College London Cancer Institute and lead investigator of the FELIX study, commented, \u201cIn the FELIX trial, AUCATZYL has shown long-term persistence and deep responses, which we believe are critical for achieving lasting remissions in B-ALL. Based on these results, AUCATZYL provides an attractive risk-benefit profile for patients with this aggressive cancer.\u201d<\/em><\/p>\n<\/blockquote>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-unicycive-s-oxylanthanum-carbonate-nda-accepted-by-fda-for-hyperphosphatemia-in-dialysis-patients\"><span class=\"ez-toc-section\" id=\"Unicycives_Oxylanthanum_Carbonate_NDA_Accepted_by_FDA_for_Hyperphosphatemia_in_Dialysis_Patients\"><\/span>Unicycive&#8217;s Oxylanthanum Carbonate NDA Accepted by FDA for Hyperphosphatemia in Dialysis Patients<span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p>Unicycive Therapeutics, Inc., a clinical-stage biotechnology company, announced that the FDA has accepted its New Drug Application (NDA) for Oxylanthanum Carbonate. The FDA has set a Prescription Drug User Fee Act (PDUFA) target action date of June 28, 2025. If approved, OLC could provide a significant improvement in the <a href=\"https:\/\/www.delveinsight.com\/report-store\/hyperphosphatemia-market\" class=\"ek-link\">treatment of hyperphosphatemia<\/a> in patients with <a href=\"https:\/\/www.delveinsight.com\/report-store\/chronic-kidney-disease-chronic-renal-failure-market\" class=\"ek-link\">chronic kidney disease <\/a>on dialysis, reducing the treatment burden that these patients currently face.<\/p>\n\n\n\n<blockquote class=\"wp-block-quote is-layout-flow wp-block-quote-is-layout-flow\">\n<p><em>\u201cWe are thrilled with the FDA acceptance of our first NDA, a significant milestone towards our efforts to bring this important treatment option to patients with kidney disease if approved,\u201d said Shalabh Gupta, MD, Chief Executive Officer of Unicycive. \u201cCKD patients on dialysis with hyperphosphatemia are often saddled with an onerous treatment regimen that includes having to take as many as 12 pills per day. OLC may have meaningful patient adherence benefits over currently available treatment options as it requires a lower pill burden for patients in terms of the number and size of pills per dose, and the pills are swallowed instead of chewed for added convenience. With our NDA now under review, we are preparing to commercialize and launch OLC in the second half of 2025, if approved.\u201d<\/em><\/p>\n<\/blockquote>\n\n\n\n<p>Unicycive is pursuing FDA approval of OLC via the 505(b)(2) regulatory pathway, with the NDA submission supported by data from three clinical studies and a robust preclinical research package. The company also highlighted that OLC is protected by a strong global patent portfolio, with exclusivity until 2031, potentially extending to 2035. Additionally, the FDA granted a waiver for PDUFA fees, providing Unicycive with savings of approximately $4 million.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-astrazeneca-amgen-report-positive-chronic-rhinosinusitis-trial-results-but-face-regulatory-hurdles\"><span class=\"ez-toc-section\" id=\"AstraZenecaAmgen_Report_Positive_Chronic_Rhinosinusitis_Trial_Results_But_Face_Regulatory_Hurdles\"><\/span>AstraZeneca\/Amgen Report Positive Chronic Rhinosinusitis Trial Results, But Face Regulatory Hurdles<span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p>AstraZeneca and Amgen announced that their subcutaneous antibody <strong>TEZSPIRE<\/strong> (tezepelumab) achieved the primary endpoint in the <strong>Phase III WAYPOINT study<\/strong> for <strong><a href=\"https:\/\/www.delveinsight.com\/report-store\/chronic-rhinosinusitis-with-nasal-polyps-market\" class=\"ek-link\">c<\/a><\/strong><a href=\"https:\/\/www.delveinsight.com\/report-store\/chronic-rhinosinusitis-with-nasal-polyps-market\" class=\"ek-link\"><strong>hronic rhinosinusitis with nasal polyps<\/strong><\/a>, demonstrating a &#8220;statistically significant and clinically meaningful&#8221; reduction in nasal polyp size and congestion compared to placebo. Tezspire, which already has FDA approval for severe asthma, maintained a safety profile consistent with previous trials, according to the companies. Specific data was not disclosed, and no immediate plans to file for CRSwNP approval were mentioned.<\/p>\n\n\n\n<blockquote class=\"wp-block-quote is-layout-flow wp-block-quote-is-layout-flow\">\n<p><em>Commenting on the announcement, William Blair analyst Matt Phipps noted that only one study has been conducted for Tezspire in CRSwNP, contrasting with Sanofi and Regeneron\u2019s Dupixent (dupilumab), which was FDA-approved for CRSwNP in 2019 after two pivotal trials. &#8220;Ahead of the full data, we do not expect Tezspire to necessarily beat Dupixent on efficacy,&#8221; Phipps stated, highlighting that CRSwNP patients typically exhibit high type-2 inflammation\u2014specifically targeted by Dupixent. In contrast, Tezspire targets TSLP cytokine, a key initiator in multiple inflammatory pathways associated with asthma, chronic obstructive pulmonary disease, and CRSwNP.<\/em><\/p>\n<\/blockquote>\n\n\n\n<blockquote class=\"wp-block-quote is-layout-flow wp-block-quote-is-layout-flow\">\n<p><strong><em>Sharon Barr<\/em><\/strong><em>, executive vice president of BioPharmaceuticals R&amp;D at AstraZeneca, expressed enthusiasm, saying, \u201cThese findings reinforce that Tezepelumab\u2019s first-in-class mode of action effectively addresses the multiple drivers of epithelial-driven inflammatory diseases.\u201d The companies plan to submit these data to regulatory authorities and present them at an upcoming medical congress.<\/em><\/p>\n<\/blockquote>\n\n\n\n<p>This recent success in the WAYPOINT study comes shortly after GSK\u2019s <strong>depemokimab<\/strong> Phase III results in September, which showed significant efficacy in reducing asthma exacerbations and hospital visits. Like Tezspire, depemokimab is being developed for both severe asthma and CRSwNP, with coordinated regulatory filings planned for these indications.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-nipocalimab-receives-fda-breakthrough-therapy-designation-for-moderate-to-severe-sjogren-s-disease\"><span class=\"ez-toc-section\" id=\"Nipocalimab_Receives_FDA_Breakthrough_Therapy_Designation_for_Moderate-to-Severe_Sjogrens_Disease\"><\/span>Nipocalimab Receives FDA Breakthrough Therapy Designation for Moderate-to-Severe Sj\u00f6gren\u2019s Disease<span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p>Johnson &amp; Johnson announced that the FDA has granted <strong>Breakthrough Therapy Designation<\/strong> to <strong>nipocalimab<\/strong> for the treatment of adults with <a href=\"https:\/\/www.delveinsight.com\/report-store\/sjogrens-syndrome-market-size\" class=\"ek-link\">moderate-to-severe <\/a><strong><a href=\"https:\/\/www.delveinsight.com\/report-store\/sjogrens-syndrome-market-size\" class=\"ek-link\">Sj\u00f6gren\u2019s d<\/a><\/strong><a href=\"https:\/\/www.delveinsight.com\/report-store\/sjogrens-syndrome-market-size\" class=\"ek-link\"><strong>isease<\/strong><\/a>. This autoimmune disease affects multiple organs and lacks approved advanced treatments. Nipocalimab, the first investigational therapy to receive this designation for SjD, previously earned BTD for treating severe <strong>hemolytic disease of the fetus and newborn<\/strong> (HDFN) in alloimmunized pregnant individuals.<\/p>\n\n\n\n<p>This FDA designation is supported by data from the <strong>Phase II DAHLIAS study<\/strong>, where nipocalimab demonstrated positive results in addressing SjD symptoms. A <strong>Phase 3 study<\/strong> is currently underway to further evaluate its safety and efficacy. Nipocalimab\u2019s DAHLIAS study findings were also presented at the <strong>2024 EULAR Congress<\/strong>, marking the first success of an investigational FcRn blocker for SjD.<\/p>\n\n\n\n<blockquote class=\"wp-block-quote is-layout-flow wp-block-quote-is-layout-flow\">\n<p><em>&#8220;Today\u2019s announcement represents a critical milestone for our work with nipocalimab,&#8221; said <\/em><strong><em>Terence Rooney<\/em><\/strong><em>, Vice President of Rheumatology at Johnson &amp; Johnson Innovative Medicine. &#8220;With no treatments currently approved to address SjD\u2019s underlying causes, there is an urgent need for innovation to improve patient outcomes.&#8221;<\/em><\/p>\n<\/blockquote>\n\n\n\n<blockquote class=\"wp-block-quote is-layout-flow wp-block-quote-is-layout-flow\">\n<p><em>SjD can significantly impact life quality, with many experiencing systemic symptoms and a heightened risk of severe conditions like B-cell lymphomas. This breakthrough designation expedites nipocalimab\u2019s development to potentially offer a targeted therapy for SjD, a disease associated with increased morbidity and mortality.<\/em><\/p>\n<\/blockquote>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-abbvie-s-schizophrenia-drug-fails-in-two-studies\"><span class=\"ez-toc-section\" id=\"AbbVies_Schizophrenia_Drug_Fails_in_Two_Studies\"><\/span>AbbVie\u2019s Schizophrenia Drug Fails in Two Studies<span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p>AbbVie recently reported that its two Phase II EMPOWER trials, which investigated emraclidine as a once-daily oral monotherapy for <a href=\"https:\/\/www.delveinsight.com\/report-store\/schizophrenia-market\" class=\"ek-link\">schizophrenia patients experiencing acute psychotic <\/a>symptoms, did not meet the primary endpoint. Specifically, the trials failed to show a statistically significant reduction in the Positive and Negative Syndrome Scale (PANSS) total score when compared to placebo after six weeks. Despite these disappointing results, AbbVie emphasized that emraclidine was well-tolerated, with adverse events comparable to those seen in earlier studies.<\/p>\n\n\n\n<blockquote class=\"wp-block-quote is-layout-flow wp-block-quote-is-layout-flow\">\n<p><em>Roopal Thakkar, M.D., executive vice president of research and development at AbbVie, commented, \u201cWhile we are disappointed with the results, we are continuing to analyze the data to determine next steps.\u201d He added, \u201cWe would like to extend our gratitude to the study participants and their loved ones as well as to our network of clinical investigative sites for their participation in these trials. We are confident that our innovative pipeline will continue to bring meaningful therapies to patients, and we remain committed to finding better treatments for people living with psychiatric and neurological disorders.\u201d<\/em><\/p>\n<\/blockquote>\n\n\n\n<p>AbbVie\u2019s neuroscience portfolio remains central to its research focus, particularly after the recent <strong>Cerevel<\/strong> acquisition, which brought multiple clinical-stage and preclinical candidates that align with AbbVie\u2019s pipeline in psychiatry, migraine, and Parkinson\u2019s disease. With promising options beyond emraclidine, AbbVie is optimistic about the potential for innovative therapies in treating complex neurological conditions.<\/p>\n","protected":false},"excerpt":{"rendered":"<p>FDA Approves Autolus&#8217;s AUCATZYL for Relapsed\/Refractory B-cell Acute Lymphoblastic Leukemia Autolus Therapeutics has achieved a significant milestone with FDA approval for AUCATZYL (obecabtagene autoleucel), a next-generation CAR T-cell therapy for adults with relapsed or refractory B-cell acute lymphoblastic leukemia (R\/R B-ALL). This approval, granted based on results from the FELIX clinical trial, highlights the therapy&#8217;s [&hellip;]<\/p>\n","protected":false},"author":20,"featured_media":30296,"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":[17564,3702,22099,204,704,349,420,639,5789,1519],"industry":[17225],"therapeutic_areas":[17240,17230,17245,17228,17236],"class_list":["post-30295","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-notizia","tag-acute-lymphoblastic-leukemia","tag-chronic-kidney-disease","tag-chronic-rhinosinusitis-with-nasal-polyposis","tag-delveinsight","tag-fda","tag-latest-pharma-news","tag-news","tag-pharma-news","tag-recent-pharma-news","tag-schizophrenia","industry-pharmaceutical","therapeutic_areas-endocrinology-and-metabolic-disorders","therapeutic_areas-genito-urinary-system-and-sex-hormones","therapeutic_areas-neurology","therapeutic_areas-oncology","therapeutic_areas-otolaryngology"],"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 | Autolus, Unicycive, AbbVie<\/title>\n<meta name=\"description\" content=\"AUCATZYL Approved, Oxylanthanum NDA Accepted, AstraZeneca-Amgen Trial Success, Nipocalimab Breakthrough, AbbVie Schizophrenia Setback\" \/>\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-autolus-unicycive-abbvie\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Pharma News | Autolus, Unicycive, AbbVie\" \/>\n<meta property=\"og:description\" content=\"AUCATZYL Approved, Oxylanthanum NDA Accepted, AstraZeneca-Amgen Trial Success, Nipocalimab Breakthrough, AbbVie Schizophrenia Setback\" \/>\n<meta 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