{"id":65399,"date":"2026-05-15T13:57:42","date_gmt":"2026-05-15T05:57:42","guid":{"rendered":"https:\/\/flcube.com\/?p=65399"},"modified":"2026-05-15T13:57:43","modified_gmt":"2026-05-15T05:57:43","slug":"amgens-izervay-nda-accepted-by-nmpa-for-geographic-atrophy-secondary-to-age-related-macular-degeneration","status":"publish","type":"post","link":"https:\/\/flcube.com\/?p=65399","title":{"rendered":"Amgen&#8217;s Izervay NDA Accepted by NMPA for Geographic Atrophy Secondary to Age-Related Macular Degeneration"},"content":{"rendered":"\n<p class=\"wp-block-paragraph\"><strong>Amgen Inc.<\/strong> (<a href=\"https:\/\/www.google.com\/finance\/quote\/AMGN:NASDAQ\">NASDAQ: AMGN<\/a>) announced that China&#8217;s <strong>National Medical Products Administration (NMPA)<\/strong> has accepted for review a <strong>New Drug Application (NDA)<\/strong> for <strong>Izervay (avacincaptad pegol, ACP)<\/strong>, seeking approval for the treatment of <strong>geographic atrophy (GA)<\/strong> secondary to <strong>age-related macular degeneration (AMD)<\/strong>.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-regulatory-milestone\">Regulatory Milestone<\/h2>\n\n\n\n<figure class=\"wp-block-table\"><table class=\"has-fixed-layout\"><thead><tr><th>Item<\/th><th>Detail<\/th><\/tr><\/thead><tbody><tr><td><strong>Agency<\/strong><\/td><td>NMPA (China)<\/td><\/tr><tr><td><strong>Application Type<\/strong><\/td><td>New Drug Application (NDA) accepted for review<\/td><\/tr><tr><td><strong>Product<\/strong><\/td><td>Izervay (avacincaptad pegol, ACP)<\/td><\/tr><tr><td><strong>Indication<\/strong><\/td><td>Geographic atrophy secondary to age-related macular degeneration<\/td><\/tr><tr><td><strong>Acquisition Details<\/strong><\/td><td>Licensed from Iveric Bio in July 2023 for USD 5.9 billion<\/td><\/tr><tr><td><strong>US Approval<\/strong><\/td><td>August 2023<\/td><\/tr><tr><td><strong>Review Basis<\/strong><\/td><td>GATHER1 and GATHER2 pivotal studies + high unmet medical need<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n<p class=\"wp-block-paragraph\">This NDA acceptance represents Amgen&#8217;s strategic entry into China&#8217;s ophthalmology market, targeting a condition with no currently approved treatments in the country.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-drug-profile-amp-mechanism-of-action\">Drug Profile &amp; Mechanism of Action<\/h2>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong>Molecule:<\/strong> Avacincaptad pegol (ACP), a synthetic aptamer<\/li>\n\n\n\n<li><strong>Target:<\/strong> Complement C5 protein<\/li>\n\n\n\n<li><strong>Mechanism:<\/strong> Inhibits overactivation of the complement system, reducing retinal cell degeneration and slowing GA progression<\/li>\n\n\n\n<li><strong>Administration:<\/strong> Monthly intravitreal injection (2 mg dose)<\/li>\n\n\n\n<li><strong>Therapeutic Rationale:<\/strong> Complement system overactivation drives scarring and vision loss in GA secondary to AMD<\/li>\n<\/ul>\n\n\n\n<p class=\"wp-block-paragraph\">Izervay&#8217;s targeted approach addresses the root cause of GA progression rather than merely managing symptoms, representing a paradigm shift in AMD treatment.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-clinical-evidence-summary\">Clinical Evidence Summary<\/h2>\n\n\n\n<figure class=\"wp-block-table\"><table class=\"has-fixed-layout\"><thead><tr><th>Study<\/th><th>Phase<\/th><th>Primary Endpoint<\/th><th>GA Lesion Growth Reduction (12 months)<\/th><\/tr><\/thead><tbody><tr><td><strong>GATHER1<\/strong><\/td><td>II\/III<\/td><td>Statistically significant<\/td><td><strong>35% reduction<\/strong> vs. sham<\/td><\/tr><tr><td><strong>GATHER2<\/strong><\/td><td>III<\/td><td>Statistically significant<\/td><td><strong>18% reduction<\/strong> vs. sham<\/td><\/tr><tr><td><strong>Combined Analysis<\/strong><\/td><td>Pivotal<\/td><td>Met with robust statistical significance<\/td><td>Consistent benefit across studies<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n<p class=\"wp-block-paragraph\">Both pivotal trials demonstrated that monthly 2 mg intravitreal injections significantly slowed the rate of GA lesion expansion compared to sham treatment, establishing a clinically meaningful benefit for patients with progressive vision loss.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-competitive-landscape-amp-market-opportunity\">Competitive Landscape &amp; Market Opportunity<\/h2>\n\n\n\n<figure class=\"wp-block-table\"><table class=\"has-fixed-layout\"><thead><tr><th>Therapeutic Status<\/th><th>China<\/th><th>Global Context<\/th><\/tr><\/thead><tbody><tr><td><strong>Approved GA treatments<\/strong><\/td><td>None currently approved<\/td><td>Syfovre (pegcetacoplan) and Izervay approved in US<\/td><\/tr><tr><td><strong>Pipeline candidates<\/strong><\/td><td>Limited visibility<\/td><td>Multiple complement inhibitors in development<\/td><\/tr><tr><td><strong>Patient population<\/strong><\/td><td>Estimated 3-5 million GA patients<\/td><td>Represents largest untapped ophthalmology market globally<\/td><\/tr><tr><td><strong>Treatment gap<\/strong><\/td><td>Complete absence of disease-modifying therapies<\/td><td>High unmet medical need acknowledged by NMPA<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n<p class=\"wp-block-paragraph\">China&#8217;s GA market represents one of the largest untapped opportunities in ophthalmology, with an aging population driving increasing prevalence of AMD and its complications.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-strategic-implications-for-amgen\">Strategic Implications for Amgen<\/h2>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong>Geographic Expansion:<\/strong> Successful approval would establish Amgen&#8217;s first ophthalmology franchise in China<\/li>\n\n\n\n<li><strong>Premium Pricing Potential:<\/strong> First-mover advantage in a high-unmet-need indication supports premium reimbursement<\/li>\n\n\n\n<li><strong>Franchise Building:<\/strong> Validates Amgen&#8217;s $5.9 billion acquisition of Iveric Bio and opens door for additional ophthalmology pipeline assets<\/li>\n\n\n\n<li><strong>Healthcare System Impact:<\/strong> Addresses critical gap in China&#8217;s eye care services, potentially qualifying for expedited reimbursement pathways<\/li>\n<\/ul>\n\n\n\n<p class=\"wp-block-paragraph\">The NMPA&#8217;s acceptance of the NDA, coupled with explicit recognition of high unmet medical need, suggests favorable regulatory conditions for potential approval in 2027.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>Forward\u2011Looking Statements<\/strong><br>This brief contains forward-looking statements regarding regulatory approvals, clinical development timelines, and commercial potential for Izervay. Actual results may differ due to risks including final regulatory decisions, competitive dynamics, and market access challenges.<a href=\"https:\/\/flcube.com\/\">-Fineline Info &amp; Tech<\/a><\/p>\n","protected":false},"excerpt":{"rendered":"<p>Amgen Inc. (NASDAQ: AMGN) announced that China&#8217;s National Medical Products Administration (NMPA) has accepted for&#8230;<\/p>\n","protected":false},"author":1,"featured_media":65400,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"googlesitekit_rrm_CAownpewDA:productID":"","_jetpack_newsletter_access":"","_jetpack_dont_email_post_to_subs":false,"_jetpack_newsletter_tier_id":0,"_jetpack_memberships_contains_paywalled_content":false,"_jetpack_feature_clip_id":0,"_jetpack_memberships_contains_paid_content":false,"footnotes":"","jetpack_publicize_message":"","jetpack_publicize_feature_enabled":true,"jetpack_social_post_already_shared":true,"jetpack_social_options":{"image_generator_settings":{"template":"highway","default_image_id":0,"font":"","enabled":false},"version":2},"jetpack_post_was_ever_published":false},"categories":[7,11],"tags":[330,38,912],"class_list":["post-65399","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-company","category-drug","tag-amgen","tag-market-approval-filings","tag-nasdaq-amgn"],"yoast_head":"<!-- This site is optimized with the Yoast SEO Premium plugin v27.5 (Yoast SEO v27.8) - https:\/\/yoast.com\/product\/yoast-seo-premium-wordpress\/ -->\n<title>Amgen&#039;s Izervay NDA Accepted by NMPA for Geographic Atrophy Secondary to Age-Related Macular Degeneration - Insight, China&#039;s Pharmaceutical Industry<\/title>\n<meta name=\"description\" content=\"Amgen Inc. (NASDAQ: AMGN) announced that China&#039;s National Medical Products Administration (NMPA) has accepted for review a New Drug Application (NDA) for Izervay (avacincaptad pegol, ACP), seeking approval for the treatment of geographic atrophy (GA) secondary to age-related macular degeneration (AMD).\" \/>\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=65399\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Amgen&#039;s Izervay NDA Accepted by NMPA for Geographic Atrophy Secondary to Age-Related Macular Degeneration\" \/>\n<meta property=\"og:description\" content=\"Amgen Inc. 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(NASDAQ: AMGN) announced that China's National Medical Products Administration (NMPA) has accepted for review a New Drug Application (NDA) for Izervay (avacincaptad pegol, ACP), seeking approval for the treatment of geographic atrophy (GA) secondary to age-related macular degeneration (AMD).","breadcrumb":{"@id":"https:\/\/flcube.com\/?p=65399#breadcrumb"},"inLanguage":"en-US","potentialAction":[{"@type":"ReadAction","target":["https:\/\/flcube.com\/?p=65399"]}]},{"@type":"ImageObject","inLanguage":"en-US","@id":"https:\/\/flcube.com\/?p=65399#primaryimage","url":"https:\/\/flcube.com\/wp-content\/uploads\/2026\/05\/1502.webp","contentUrl":"https:\/\/flcube.com\/wp-content\/uploads\/2026\/05\/1502.webp","width":1080,"height":608,"caption":"Amgen's Izervay NDA Accepted by NMPA for Geographic Atrophy Secondary to Age-Related Macular Degeneration"},{"@type":"BreadcrumbList","@id":"https:\/\/flcube.com\/?p=65399#breadcrumb","itemListElement":[{"@type":"ListItem","position":1,"name":"Home","item":"https:\/\/flcube.com\/"},{"@type":"ListItem","position":2,"name":"Amgen&#8217;s Izervay NDA Accepted by NMPA for Geographic Atrophy Secondary to Age-Related Macular Degeneration"}]},{"@type":"WebSite","@id":"https:\/\/flcube.com\/#website","url":"https:\/\/flcube.com\/","name":"Insight, China's Pharmaceutical Industry","description":"Fineline Insights, Pharma Clarity","publisher":{"@id":"https:\/\/flcube.com\/#organization"},"potentialAction":[{"@type":"SearchAction","target":{"@type":"EntryPoint","urlTemplate":"https:\/\/flcube.com\/?s={search_term_string}"},"query-input":{"@type":"PropertyValueSpecification","valueRequired":true,"valueName":"search_term_string"}}],"inLanguage":"en-US"},{"@type":"Organization","@id":"https:\/\/flcube.com\/#organization","name":"Fineline Infomation and Technology","alternateName":"Fineline Info & Tech","url":"https:\/\/flcube.com\/","logo":{"@type":"ImageObject","inLanguage":"en-US","@id":"https:\/\/flcube.com\/#\/schema\/logo\/image\/","url":"https:\/\/flcube.com\/wp-content\/uploads\/2024\/11\/Fineline-info-tech-scaled.jpg","contentUrl":"https:\/\/flcube.com\/wp-content\/uploads\/2024\/11\/Fineline-info-tech-scaled.jpg","width":2560,"height":1894,"caption":"Fineline Infomation and Technology"},"image":{"@id":"https:\/\/flcube.com\/#\/schema\/logo\/image\/"},"sameAs":["https:\/\/www.facebook.com\/profile.php?id=61566606313834"]},{"@type":"Person","@id":"https:\/\/flcube.com\/#\/schema\/person\/19ad11870d326204db8524d3c3c5e66a","name":"Fineline Cube","image":{"@type":"ImageObject","inLanguage":"en-US","@id":"https:\/\/secure.gravatar.com\/avatar\/89f733aaed3d2d91d7d6f45d0e9ab509e3004e8243c6e57620b36380684657f2?s=96&d=mm&r=g","url":"https:\/\/secure.gravatar.com\/avatar\/89f733aaed3d2d91d7d6f45d0e9ab509e3004e8243c6e57620b36380684657f2?s=96&d=mm&r=g","contentUrl":"https:\/\/secure.gravatar.com\/avatar\/89f733aaed3d2d91d7d6f45d0e9ab509e3004e8243c6e57620b36380684657f2?s=96&d=mm&r=g","caption":"Fineline Cube"},"sameAs":["https:\/\/flcube.com"],"url":"https:\/\/flcube.com\/?author=1"}]}},"jetpack_publicize_connections":[],"jetpack_featured_media_url":"https:\/\/flcube.com\/wp-content\/uploads\/2026\/05\/1502.webp","jetpack_sharing_enabled":true,"_links":{"self":[{"href":"https:\/\/flcube.com\/index.php?rest_route=\/wp\/v2\/posts\/65399","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/flcube.com\/index.php?rest_route=\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/flcube.com\/index.php?rest_route=\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/flcube.com\/index.php?rest_route=\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/flcube.com\/index.php?rest_route=%2Fwp%2Fv2%2Fcomments&post=65399"}],"version-history":[{"count":1,"href":"https:\/\/flcube.com\/index.php?rest_route=\/wp\/v2\/posts\/65399\/revisions"}],"predecessor-version":[{"id":65401,"href":"https:\/\/flcube.com\/index.php?rest_route=\/wp\/v2\/posts\/65399\/revisions\/65401"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/flcube.com\/index.php?rest_route=\/wp\/v2\/media\/65400"}],"wp:attachment":[{"href":"https:\/\/flcube.com\/index.php?rest_route=%2Fwp%2Fv2%2Fmedia&parent=65399"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/flcube.com\/index.php?rest_route=%2Fwp%2Fv2%2Fcategories&post=65399"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/flcube.com\/index.php?rest_route=%2Fwp%2Fv2%2Ftags&post=65399"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}