FDA to Review EYLEA (aflibercept) Injection for the Treatment of Diabetic Retinopathy
Regeneron Pharmaceuticals, Inc. (REGN)
Last regeneron pharmaceuticals, inc. earnings: 2/6 06:30 am
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Source: PR Newswire
TARRYTOWN, N.Y., Sept. 13, 2018 /PRNewswire/ -- Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) today announced that the U.S. Food and Drug Administration (FDA) has accepted for review the supplemental Biologics License Application (sBLA) of EYLEA® (aflibercept) Injection for the treatment of diabetic retinopathy (DR), the leading cause of vision loss for patients with diabetes. The target action date for the FDA decision is May 13, 2019.The sBLA submission is based on results from the Phase 3 PANORAMA trial investigating EYLEA as a treatment for patients with moderately severe to severe non-proliferative diabetic retinopathy (NPDR) without diabetic macular edema (DME). Positive six-month topline results from PANORAMA were announced in March 2018. One-year results from PANORAMA are expected to be shared later this year. The safety and efficacy of the potential use of EYLEA in DR without DME has not been fully evaluated by any regulatory authority.EYLEA is administered as a 2 mg intravi
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