{"id":50327,"date":"2023-08-19T00:56:18","date_gmt":"2023-08-19T04:56:18","guid":{"rendered":"https:\/\/ifintechworld.com\/uncategorized\/us-fda-approves-higher-dose-of-regenerons-eye-disease-drug-eylea\/"},"modified":"2023-08-19T00:56:20","modified_gmt":"2023-08-19T04:56:20","slug":"us-fda-approves-higher-dose-of-regenerons-eye-disease-drug-eylea","status":"publish","type":"post","link":"https:\/\/ifintechworld.com\/?p=50327","title":{"rendered":"US FDA approves higher dose of Regeneron’s eye disease drug Eylea"},"content":{"rendered":"
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\u00a9 Reuters. FILE PHOTO: Signage is seen outside of the Food and Drug Administration (FDA) headquarters in White Oak, Maryland, U.S., August 29, 2020. REUTERS\/Andrew Kelly\/File Photo<\/span>
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By Jahnavi Nidumolu<\/p>\n

(Reuters) -The U.S. Food and Drug Administration approved a higher dose version of Regeneron (NASDAQ:) Pharmaceuticals’ drug Eylea for treatment of a disease that is a leading cause of blindness among the elderly, the company said in a statement on Friday. <\/p>\n

The drug, Eylea HD, is priced at $2,625 per single-use vial in the U.S. and is used to treat patients with wet age-related macular degeneration (AMD), diabetic macular edema (DME) and diabetic retinopathy (DR), Regeneron said. <\/p>\n

Eylea, which is jointly developed with Bayer (OTC:), is normally given in doses of 2 milligrams every eight weeks. Two late-stage trials had shown Eylea was as effective as the lower dose version when given at 8 mg at longer intervals without any additional safety issues.<\/p>\n

In June, the FDA declined to approve the higher dose version of Eylea and said it had outstanding questions, citing an ongoing review of inspection at third-party manufacturer Catalent (NYSE:) . <\/p>\n

Earlier in the day, the FDA approved another Regeneron drug, branded as Veopoz to treat a rare blood disease CHAPLE. <\/p>\n

With Veopoz’s approval, the company said earlier that the pre-approval inspection issues related to the marketing application of Eylea HD, or aflibercept, has been addressed.<\/p>\n

An estimated 1.4 million people in the U.S. have wet AMD, according to Regeneron. <\/p>\n<\/div>\n

Read the full article here<\/a><\/p>\n","protected":false},"excerpt":{"rendered":"

\u00a9 Reuters. FILE PHOTO: Signage is seen outside of the Food and Drug Administration (FDA) headquarters in White Oak, Maryland, U.S., August 29, 2020. REUTERS\/Andrew Kelly\/File Photo By Jahnavi Nidumolu (Reuters) -The U.S. Food and Drug Administration approved a higher dose version of Regeneron (NASDAQ:) Pharmaceuticals’ drug Eylea for treatment of a disease that is […]<\/p>\n","protected":false},"author":1,"featured_media":657,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"video","meta":{"footnotes":""},"categories":[1],"tags":[83],"class_list":["post-50327","post","type-post","status-publish","format-video","has-post-thumbnail","hentry","category-uncategorized","tag-featured","post_format-post-format-video"],"yoast_head":"\nUS FDA approves higher dose of Regeneron's eye disease drug Eylea | iFintechWorld<\/title>\n<meta name=\"description\" content=\"\u00a9 Reuters. 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