Industry News — Clinical Updates
FDA Grants Breakthrough Therapy Designation to Eylea for DME
The US Food and Drug Administration (FDA) has granted Eylea (aflibercept, Regeneron Pharmaceuticals, Inc., Tarrytown, NY) its Injection Breakthrough Therapy designation for the treatment of diabetic retinopathy in patients with diabetic macular edema (DME). The FDA based the designation on positive results in the VIVID-DME and VISTA-DME Phase 3 trials, in which Eylea demonstrated a statistically significant improvement in a prespecified measure of diabetic retinopathy in patients with DME after 2 years of treatment.
The FDA created the Breakthrough Therapy designation to expedite the development and review of drugs for serious or life-threatening conditions. Drugs qualifying for this designation must show credible evidence of a substantial improvement on a clinically significant endpoint over available therapies, or placebo if there is no available therapy. The designation includes all of the fast-track program features, as well as more intensive FDA guidance and discussion. The Breakthrough Therapy designation is distinct from both accelerated approval and priority review, which can also be granted to the same drug if relevant criteria are met.
Eylea is approved in the United States, European Union (EU), and other countries for the treatment of wet AMD, CRVO, and DME. Regulatory submissions have been made in the US and EU for Eylea for macular edema following BRVO.
Updated September 18, 2014