By Connor Hart
Regeneron Pharmaceuticals said it is working to determine a path forward for its treatment of several retinal conditions after the Food and Drug Administration said it didn't agree with the company's proposal to extend the interval between doses.
The FDA told Regeneron in a complete response letter that while it didn't identify any issues with the safety or efficacy of the drug in its approved indications and dosing regimens, the agency didn't agree with Regeneron's proposal to add additional extended dosing intervals
The company previously submitted a supplemental biologics license application for the addition of extended dosing intervals of up to 24 weeks for the drug, across all its approved applications.
The Tarrytown, N.Y., biotech company said Friday its treatment, Eylea HD, is approved with dosing intervals from every eight to 16 weeks for patients with wet age-related macular degeneration and diabetic macular edema, and every eight to 12 weeks for patients with diabetic retinopathy. These dosing intervals follow three initial monthly doses.
Regeneron said it is evaluating the FDA's decision and will determine a path forward in due course.
Write to Connor Hart at connor.hart@wsj.com
(END) Dow Jones Newswires
April 18, 2025 15:37 ET (19:37 GMT)
Copyright (c) 2025 Dow Jones & Company, Inc.
免責聲明：投資有風險，本文並非投資建議，以上內容不應被視為任何金融產品的購買或出售要約、建議或邀請，作者或其他用戶的任何相關討論、評論或帖子也不應被視為此類內容。本文僅供一般參考，不考慮您的個人投資目標、財務狀況或需求。TTM對信息的準確性和完整性不承擔任何責任或保證，投資者應自行研究並在投資前尋求專業建議。