{"id":13801,"date":"2024-11-20T17:22:30","date_gmt":"2024-11-20T09:22:30","guid":{"rendered":"https:\/\/flcube.com\/?p=13801"},"modified":"2024-11-20T17:22:33","modified_gmt":"2024-11-20T09:22:33","slug":"astellas-pharmas-izervay-snda-for-geographic-atrophy-receives-fda-complete-response-letter","status":"publish","type":"post","link":"https:\/\/flcube.com\/?p=13801","title":{"rendered":"Astellas Pharma’s Izervay sNDA for Geographic Atrophy Receives FDA Complete Response Letter"},"content":{"rendered":"\n

Japan-based Astellas Pharma Inc. (TYO: 4568<\/a>) has announced that its supplemental New Drug Application (sNDA) for Izervay (avacincaptad pegol), indicated for the treatment of geographic atrophy (GA) secondary to age-related macular degeneration (AMD), has received a Complete Response Letter (CRL) from the US FDA. The CRL addresses a statistical matter related to the proposed labelling language by Astellas, rather than the safety and benefit\/risk profile of Izervay. As a result, the FDA has decided not to approve the filing in its current form by the PDUFA action date of November 19, 2024.<\/p>\n\n\n\n

Izervay’s Background and Recent Developments<\/strong>
Izervay, a novel complement C5 inhibitor, was originally developed by US biotech Iveric Bio, which was subsequently acquired by Astellas for USD 5.9 billion in July of the previous year. The sNDA aimed to incorporate positive two-year data into the U.S. Prescribing Information for the drug, based on the results from the GATHER2 Phase III clinical trial. This trial evaluated the efficacy and safety of monthly (EM) and every other month (EOM) dosing through year 2. Izervay was approved by the FDA on August 4, 2023, for the treatment of GA secondary to AMD.<\/p>\n\n\n\n

Astellas’ Next Steps with the FDA<\/strong>
Astellas is seeking further clarification from the FDA and is committed to working closely with the agency to promptly address the feedback received. The company’s proactive approach demonstrates its dedication to resolving the statistical labelling concerns and to ensuring the continued development and potential expansion of Izervay’s prescribing information in the United States.<\/p>\n\n\n\n

<\/p>\n","protected":false},"excerpt":{"rendered":"

Japan-based Astellas Pharma Inc. (TYO: 4568) has announced that its supplemental New Drug Application (sNDA)…<\/p>\n","protected":false},"author":1,"featured_media":13802,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"googlesitekit_rrm_CAownpewDA:productID":"","_jetpack_memberships_contains_paid_content":false,"footnotes":"","jetpack_publicize_message":"","jetpack_publicize_feature_enabled":true,"jetpack_social_post_already_shared":false,"jetpack_social_options":{"image_generator_settings":{"template":"highway","default_image_id":0,"font":"","enabled":false},"version":2}},"categories":[7,11],"tags":[353,44,978],"class_list":["post-13801","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-company","category-drug","tag-astellas-pharma","tag-ophthalmology","tag-tyo-4568"],"yoast_head":"\nAstellas Pharma's Izervay sNDA for Geographic Atrophy Receives FDA Complete Response Letter - Insight, China's Pharmaceutical Industry<\/title>\n<meta name=\"description\" content=\"Japan-based Astellas Pharma Inc. (TYO: 4568) has announced that its supplemental New Drug Application (sNDA) for Izervay (avacincaptad pegol), indicated for the treatment of geographic atrophy (GA) secondary to age-related macular degeneration (AMD), has received a Complete Response Letter (CRL) from the US FDA. The CRL addresses a statistical matter related to the proposed labelling language by Astellas, rather than the safety and benefit\/risk profile of Izervay. As a result, the FDA has decided not to approve the filing in its current form by the PDUFA action date of November 19, 2024.\" \/>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/flcube.com\/?p=13801\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Astellas Pharma's Izervay sNDA for Geographic Atrophy Receives FDA Complete Response Letter\" \/>\n<meta property=\"og:description\" content=\"Navigate the complexities of China\u2019s pharmaceutical industry with precision and clarity. FLCUBE delivers reliable data, news, and intelligence to broaden your horizons and sharpen your decision-making. 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