FDA accepts Regeneron's EYLEA Injection sBLA for standard review

Published on December 18, 2013 at 8:11 AM · No Comments

Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) today announced that the U.S. Food and Drug Administration (FDA) has accepted for standard review the Company's supplemental Biologics License Application (sBLA) for EYLEA® (aflibercept) Injection for the treatment of Diabetic Macular Edema (DME). Under the Prescription Drug User Fee Act (PDUFA), the goal for a standard review of an sBLA is ten months from submission, for a target action date of August 18, 2014.

"Diabetes is a growing public health concern and DME is a leading cause of vision loss in patients with diabetic retinopathy," said George D. Yancopoulos, M.D., Ph. D., Chief Scientific Officer of Regeneron and President of Regeneron Laboratories.  "We hope to be able to offer a new treatment option to patients who suffer from diabetic macular edema."

The EYLEA sBLA submission is based on the positive results from the Phase 3 VIVID and VISTA trials.

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