BRIEF—FDA extends pediatric exclusivity of Regeneron's Eylea

The US Food and Drug Administration (FDA) has granted pediatric exclusivity for Regeneron Pharmaceuticals’ Eylea (aflibercept) Injection.

This grant extends the period of US market exclusivity for Eylea by an additional six months through May 17, 2024.

The pediatric exclusivity determination is based on data from two Phase III 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 III 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 its German partner Bayer for FIREFLEYE.