- 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 FDA’s 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.
For further details see:
Regeneron wins six-month pediatric exclusivity for Eylea in U.S. market