EYLEA® Injection Accepted for Priority Review by FDA for Diabetic Retinopathy in Patients with Diabetic Macular Edema

Monday, December 1, 2014

Source: Regeneron

Regeneron Pharmaceuticals, Inc. announced that the U.S. Food and Drug Administration (FDA) has accepted for priority review the supplemental biologics license application (sBLA) for EYLEA® (aflibercept) Injection for the treatment of diabetic retinopathy in patients with diabetic macular edema

(DME). Under the Prescription Drug User Fee Act (PDUFA), the goal for a priority review is six months, for a target action date of March 30, 2015.

In September 2014, the FDA granted EYLEA® (aflibercept) Injection Breakthrough Therapy designation for the treatment of diabetic retinopathy in patients with DME. The FDA created the Breakthrough Therapy designation to expedite the development and review of drugs for serious or life-threatening conditions. A Breakthrough Therapy drug must show preliminary clinical evidence of a substantial improvement on a clinically significant endpoint over available therapies, or over placebo if there is no available therapy.

"Diabetic retinopathy coupled with DME is a significant threat to vision for people with diabetes," said George D. Yancopoulos, M.D., Ph.D., Chief Scientific Officer of Regeneron and President of Regeneron Laboratories. "Regeneron looks forward to working with the FDA to help address this significant treatment gap in a leading cause of blindness in working-age adults."

The Phase 3 VIVID-DME and VISTA-DME trials, which supported the approval of EYLEA in DME, included a pre-specified secondary endpoint evaluating diabetic retinopathy based on an established grading scale in patients with DME. The two-year results from these trials on the primary endpoint of best-corrected visual acuity (BCVA) and overall safety have been previously reported.

EYLEA® (aflibercept) Injection is available as a single, 2 milligram (mg) strength intravitreal injection for all approved indications.

EYLEA is approved in the U.S. for the treatment of wet age-related macular degeneration (AMD), macular edema following retinal vein occlusion (RVO), and DME.

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