Regeneron to Reassess Strategy for Retinal Condition Treatment After FDA Rejects Dosing Plan
REGN
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 [email protected]
(END) Dow Jones Newswires
04-18-25 1552ET