Regeneron (NASDAQ:REGN) shares dropped more than 10% after the company received a Complete Response Letter (CRL) from the U.S. Food and Drug Administration (FDA) regarding the Biologics License Application (BLA) for aflibercept 8 mg.
The FDA issued a CRL solely because they are currently reviewing inspection findings at a third-party filler. However, there were no concerns raised about the clinical effectiveness, safety, trial design, labeling, or drug manufacturing of aflibercept 8 mg. The FDA did not request any additional clinical data or trials.
Regeneron is committed to collaborating closely with the FDA and the third-party filler to bring aflibercept 8 mg to patients with wet age-related macular degeneration (wAMD), diabetic macular edema (DME), and diabetic retinopathy (DR) as quickly as possible.