The company noted that the pediatric exclusivity determination is based on data from two Phase 3 trials – BUTTERFLEYE and FIREFLEYE.
Regeneron Pharmaceuticals announced the FDA has granted pediatric exclusivity for aflibercept injection (Eylea).
According to a news release, this grant extends the period of U.S. market exclusivity for aflibercept injection by an additional 6 months through May 17, 2024.
The company noted in the news release that 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.
Moreover, the two Phase 3 trials also formed the basis of a supplemental Biologics License Application for aflibercept injection 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 aflibercept injection for this indication have not been fully evaluated by the FDA and other regulatory authorities.
Aflibercept injection 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.
EYLEA is a VEGF inhibitor formulated as an injection for the eye. It is designed to block the growth of new blood vessels and decrease the ability of fluid to pass through blood vessels (vascular permeability) in the eye by blocking VEGF-A and placental growth factor (PLGF), two growth factors involved in angiogenesis. The aflibercept injection safety and efficacy profile is supported by a robust body of research that includes eight pivotal Phase 3 trials, 10 years of real-world experience and more than 50 million EYLEA injections globally.
According to the news release, Bayer and Regeneron are collaborating on the global development of EYLEA. Regeneron maintains exclusive rights of EYLEA in the United States. Bayer has licensed the exclusive marketing rights outside the United States, where the companies share equally the profits from sales of EYLEA.