Regeneron Receives Six Months of U.S. Pediatric Exclusivity for EYLEA® (aflibercept) Injection
Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) today announced the U.S. Food and Drug Administration (FDA) has granted pediatric exclusivity for EYLEA® (aflibercept) Injection. This grant extends the period of U.S. market exclusivity for EYLEA by an additional six months through May 17, 2024
TARRYTOWN, N.Y., Oct. 21, 2022 /PRNewswire/ -- Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) today announced the U.S. Food and Drug Administration (FDA) has granted pediatric exclusivity for EYLEA® (aflibercept) Injection. This grant extends the period of U.S. market exclusivity for EYLEA by an additional six months through May 17, 2024.
The pediatric exclusivity determination is based on data from two Phase 3 trials – BUTTERFLEYE and FIREFLEYE – which were submitted in response to the FDA's Written Request to evaluate the use of EYLEA as a treatment for retinopathy of prematurity (ROP) in preterm infants. The two Phase 3 trials also formed the basis of a supplemental Biologics License Application for EYLEA in ROP that was recently accepted for Priority Review by the FDA. The lead sponsors of the trials were Regeneron for BUTTERFLEYE and Bayer for FIREFLEYE.
EYLEA was granted orphan drug designation by the FDA for the treatment of ROP in July 2019. The safety and efficacy of EYLEA for this indication have not been fully evaluated by the FDA and other regulatory authorities.
EYLEA is currently approved in the U.S. for the treatment of patients with wet age-related macular degeneration, macular edema following retinal vein occlusion, diabetic macular edema and diabetic retinopathy.
