BTD tag for Eylea for diabetic retinopathy in DME

• The FDA designates Regeneron Pharmaceuticals' (NASDAQ:REGN) Eylea (aflibercept) a Breakthough Therapy (BTD) for the treatment of diabetic retinopathy in patients with diabetic macular edema (DME).
• Drugs tagged as Breakthrough Therapies must show credible evidence of a substantial improvement on a clinically significant endpoint over available therapies or over placebo if no therapies are available. It was created by the FDA to expedite the development and review of drugs for serious or life-threatening conditions. BTD-labelled drugs are Fast Track'd but have the additional benefit of more-intensive agency guidance and discussion.
• Eylea is currently approved for the treatment of wet age-related macular degeneration, macular edema following retinal vein occlusion and diabetic macular edema.
• The company expects to submit a supplemental BLA (sBLA) in the U.S. for diabetic retinopathy this year.