By Stephen NakrosisRegeneron Pharmaceuticals said it received a complete response letter from the Food and Drug Administration for its aflibercept 8 mg biologics license application, adding the letter involves inspection findings at a third-party filler. The company also said it is committed to working with the FDA and the third-party filler to bring aflibercept 8 mg diabetic macular edema treatment to patients as soon as possible. Aflibercept 8 mg is being jointly developed by Regeneron and Bayer AG. Regeneron also reported two-year results from a trial of aflibercept, which the company said "demonstrate durable vision gains at extended dosing intervals in diabetic macular edema." Two-year data from a trial for aflibercept 8 mg in wet age-related macular degeneration are expected in the third quarter, Regeneron said.

Source: Wall Street Journal June 28, 2023 08:29 UTC