Regeneron: FDA Grants Pediatric Exclusivity For EYLEA

(RTTNews) - Regeneron Pharmaceuticals, Inc. (REGN) announced the FDA has granted pediatric exclusivity for EYLEA Injection. This extends the period of U.S. market exclusivity for EYLEA by an additional six months through May 17, 2024. The company said 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 in preterm infants.

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.

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