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Aflibercept 8 mg BLA for Treatment of Wet Age-Related Macular Degeneration and Diabetic Macular Edema Accepted for FDA Priority Review
BLA supported by two pivotal trials demonstrating non-inferior vision gains to EYLEA® (aflibercept) Injection, with vast majority of patients maintaining
About this update from Regeneron Pharmaceuticals, Inc.
[{"type":"text","content":"BLA supported by two pivotal trials demonstrating non-inferior vision gains to EYLEA® (aflibercept) Injection, with vast majority of patients maintaining extended dosing regimens through 48 weeks If approved, aflibercept 8 mg will be second ophthalmology medicine developed by Regeneron TARRYTOWN, N.Y., Feb. 23, 2023 (GLOBE NEWSWIRE) -- Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) today announced that the U.S. Food and Drug Administration (FDA) has accepted for Priority Review the Biologics License Application (BLA) for aflibercept 8 mg for treatment of patients with wet age-related macular degeneration (wAMD), diabetic macular edema (DME) and diabetic retinopathy. The FDA target action date is June 27, 2023 following the use of a priority review voucher. The BLA is supported by positive data from two pivotal trials – PULSAR in wAMD and PHOTON in DME – that were previously presented at the 55th Annual Scientific Session of The Retina Society in November 2022. In both trials, patients treated with aflibercept 8 mg (PULSAR n=673; PHOTON n=491) met the primary endpoint of non-inferiority in vision gains for both the 12- and 16-week dosing regimens after initial monthly doses at 48 weeks compared to patients treated with an EYLEA® (aflibercept) Injection (PULSAR n=336; PHOTON n=167) 8-week dosing regimen. Additionally, the vast majority of patients randomized to aflibercept 8 mg in both trials were able to maintain the 12- and 16-week dosing regimens to which they were respectively initiated through 48 weeks (wAMD: 79% and 77%; DME: 91% and 89%). The safety profile for aflibercept 8 mg was similar to EYLEA in both trials, and consistent with the known safety profile of EYLEA from previous clinical trials. Comparing aflibercept 8 mg to EYLEA, ocular adverse events occurred in 31% (n=491) versus 28% (n=167) in PHOTON and 38% (n=673) versus 39% (n=336) in PULSAR, and there were no cases of retinal vasculitis, occlusive retinitis or endophthalmitis in either trial. Aflibercept 8 mg is being jointly developed by Regeneron and Bayer AG. In the U.S., Regeneron maintains exclusive rights to EYLEA and aflibercept 8 mg. Bayer has licensed the exclusive marketing rights outside of the U.S., where the companies share equally the profits from sales of EYLEA and future sales of aflibercept 8 mg following any regulatory approvals. Aflibercept 8 m...