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FDA accepts Eylea sBLA for Priority Review

  • The FDA accepts for Priority Review Regeneron Pharmaceuticals' (NASDAQ:REGN) supplemental biologics license application (sBLA) for Eylea (aflibercept) for the treatment of diabetic retinopathy in patients with diabetic macular edema (DME). The PDUFA date for the Breakthrough Therapy-designated indication is March 30, 2015.
  • Elyea is currently approved for the treatment of diabetic macular edema, macular edema following retinal vein occlusion and wet age-related macular degeneration.

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Regeneron Pharmaceuticals, Inc.