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Regeneron (NASDAQ:REGN) announced Tuesday that the U.S. Food and Drug Administration (FDA) declined to approve an 8 mg dose of its eye disease therapy, aflibercept.
The injection at a dose of 2 mg is already marketed in the U.S. as Eylea for conditions including wet age-related macular degeneration ((wAMD)), diabetic macular edema (DME), and diabetic retinopathy (DR).
In the Complete Response Letter (CRL), the FDA has not identified any concerns regarding the treatment’s clinical efficacy, safety, or drug substance manufacturing and has not requested additional clinical data or trials, the company said.
However, Regeneron (REGN) cited an ongoing review of findings at a third-party filler as the reason for rejection. Contract manufacturer Catalent, Inc. (CTLT) reached a session low in reaction. Regeneron (REGN) shares are currently on hold for trading.
“Regeneron is committed to working closely with the FDA and the third-party filler to bring aflibercept 8 mg to patients with wAMD, DME, and DR as quickly as possible,” the company said.
Regeneron (REGN) has partnered with Bayer AG (OTCPK:BAYZF) (OTCPK:BAYRY) to market high-dose aflibercept.
Regeneron (REGN) shares surged in September 2022 after the company said that the high-dose version showed noninferiority to the 2mg dose with less frequent administration.
