{"id":32208,"date":"2025-04-22T17:08:38","date_gmt":"2025-04-22T09:08:38","guid":{"rendered":"https:\/\/flcube.com\/?p=32208"},"modified":"2025-04-22T17:08:39","modified_gmt":"2025-04-22T09:08:39","slug":"regenerons-eylea-hd-receives-fda-complete-response-letter-despite-priority-review","status":"publish","type":"post","link":"https:\/\/flcube.com\/?p=32208","title":{"rendered":"Regeneron’s Eylea HD Receives FDA Complete Response Letter Despite Priority Review"},"content":{"rendered":"\n

Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN<\/a>) announced that it has received a Complete Response Letter (CRL) from the US Food and Drug Administration (FDA) regarding the supplemental Biologics License Application (sBLA) for Eylea HD (aflibercept) injection 8 mg. Despite being granted priority review status last week, the FDA did not agree with Regeneron’s proposal to extend dosing intervals beyond every 16 weeks, which is the maximum currently indicated in the label.<\/p>\n\n\n\n

FDA Feedback and Safety Profile<\/strong>
The CRL did not identify any issues with the safety or efficacy of Eylea HD in its approved indications and dosing regimens. The FDA’s concerns were specifically related to the proposed extended dosing intervals. Eylea HD remains approved for dosing intervals ranging from every 8 to 16 weeks for patients with wet age-related macular degeneration (wAMD) and diabetic macular edema (DME), and every 8 to 12 weeks for patients with diabetic retinopathy (DR), following three initial monthly doses.-Fineline Info & Tech<\/a><\/p>\n","protected":false},"excerpt":{"rendered":"

Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) announced that it has received a Complete Response Letter (CRL)…<\/p>\n","protected":false},"author":1,"featured_media":32209,"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":true,"jetpack_social_options":{"image_generator_settings":{"template":"highway","default_image_id":0,"font":"","enabled":false},"version":2}},"categories":[7,11],"tags":[1166,44,1426],"class_list":["post-32208","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-company","category-drug","tag-nasdaq-regn","tag-ophthalmology","tag-regeneron-pharmaceuticals"],"yoast_head":"\nRegeneron's Eylea HD Receives FDA Complete Response Letter Despite Priority Review - Insight, China's Pharmaceutical Industry<\/title>\n<meta name=\"description\" content=\"Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) announced that it has received a Complete Response Letter (CRL) from the US Food and Drug Administration (FDA) regarding the supplemental Biologics License Application (sBLA) for Eylea HD (aflibercept) injection 8 mg. Despite being granted priority review status last week, the FDA did not agree with Regeneron's proposal to extend dosing intervals beyond every 16 weeks, which is the maximum currently indicated in the label.\" \/>\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=32208\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Regeneron's Eylea HD Receives FDA Complete Response Letter Despite Priority Review\" \/>\n<meta property=\"og:description\" content=\"Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) announced that it has received a Complete Response Letter (CRL) from the US Food and Drug Administration (FDA) regarding the supplemental Biologics License Application (sBLA) for Eylea HD (aflibercept) injection 8 mg. 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