Regeneron wins six-month pediatric exclusivity for Eylea in U.S. market
Darren415


Regeneron Pharmaceuticals (NASDAQ:REGN) announced Friday that the FDA awarded pediatric exclusivity for its blockbuster eye therapy Eylea extending its U.S. market exclusivity by another six months through May 17, 2024.
The decision was backed by data from two Phase 3 trials, BUTTERFLEYE and FIREFLEYE, designed to evaluate Eylea in preterm infants with retinopathy of prematurity (ROP).

Eylea injection, also known as aflibercept, is curently under the FDAâs priority review for ROP based on data from BUTTERFLEYE and FIREFLEYE.
German healthcare company Bayer (OTCPK:BAYZF) (OTCPK:BAYRY) has partnered with Regeneron (REGN) to develop Eylea for overseas markets.

Eylea, indicated for eye conditions such as wet age-related macular degeneration, diabetic macular edema, and diabetic retinopathy, generated $5.8B of net product sales in 2021 from the U.S.