{"id":50928,"date":"2023-08-20T23:46:39","date_gmt":"2023-08-21T03:46:39","guid":{"rendered":"https:\/\/ifintechworld.com\/uncategorized\/us-fda-approves-regenerons-ultra-rare-blood-disease-drug\/"},"modified":"2023-08-20T23:46:41","modified_gmt":"2023-08-21T03:46:41","slug":"us-fda-approves-regenerons-ultra-rare-blood-disease-drug","status":"publish","type":"post","link":"https:\/\/ifintechworld.com\/?p=50928","title":{"rendered":"US FDA approves Regeneron’s ultra-rare blood disease drug"},"content":{"rendered":"
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\u00a9 Reuters. FILE PHOTO: The Regeneron Pharmaceuticals company logo is seen on a building at the company’s Westchester campus in Tarrytown, New York, U.S. September 17, 2020. REUTERS\/Brendan McDermid\/File Photo<\/span>
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By Pratik Jain<\/p>\n

(Reuters) -Regeneron Pharmaceuticals said on Friday the U.S. health regulator approved its drug to treat a rare blood disease.<\/p>\n

The drug pozelimab, branded as Veopoz, would treat CHAPLE disease in adult and pediatric patients 1 year of age and older.<\/p>\n

Veopoz \u2014 the first treatment to be approved by the U.S. Food and Drug Administration for the life-threatening disease \u2014 will be sold in the U.S. at a list price of $34,615.38 per single-use vial, the company told Reuters in an emailed response.<\/p>\n

The drug will be available in the third quarter of this year, it said.<\/p>\n

Regeneron (NASDAQ:) said the disease has fewer than 10 patients identified in the U.S. and estimates less than 100 patients worldwide.<\/p>\n

People with CHAPLE disease have mutated CD55 gene, which regulates the body’s mechanism for destroying microbes. Without proper gene regulation, the mechanism may start attacking normal cells of the body.<\/p>\n

Veopoz’s approval, however, comes with a boxed warning for serious meningococcal infections, as the treatment poses risks of developing the life-threatening bacterial infection.<\/p>\n

With Veopoz’s approval, the company said the pre-approval inspection issues related to the marketing application of the higher dose of its blockbuster eye disease drug Eylea, or aflibercept, has been addressed.<\/p>\n

The regulator’s decision on the 8mg dose of Eylea is expected in the next few weeks, the company added. <\/p>\n

Imminent approval would allow the company to quickly begin converting new patients to 8mg aflibercept ahead of biosimilar entrants, potentially preserve its Eylea franchise and future revenues from the high-dose version which could reach as high as $9.8 billion, according to BMO Capital Markets analyst Evan Seigerman.<\/p>\n

Seigerman sees biosimilars for Eylea potentially able to enter the market in May 2024.<\/p>\n

The FDA had in June declined to approve the higher-dose version following an inspection at third-party manufacturer Catalent (NYSE:).<\/p>\n<\/div>\n

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

\u00a9 Reuters. FILE PHOTO: The Regeneron Pharmaceuticals company logo is seen on a building at the company’s Westchester campus in Tarrytown, New York, U.S. September 17, 2020. REUTERS\/Brendan McDermid\/File Photo By Pratik Jain (Reuters) -Regeneron Pharmaceuticals said on Friday the U.S. health regulator approved its drug to treat a rare blood disease. The drug pozelimab, […]<\/p>\n","protected":false},"author":1,"featured_media":1374,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"video","meta":{"footnotes":""},"categories":[1],"tags":[83],"class_list":["post-50928","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 Regeneron's ultra-rare blood disease drug | iFintechWorld<\/title>\n<meta name=\"description\" content=\"\u00a9 Reuters. 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