FDA not prepared to approve highest dose of Regeneron's Eylea
The US Food and Drug Administration (FDA) has issued a Complete Response Letter (CRL) for the Biologics License Application (BLA) for aflibercept 8mg for the treatment of patients with wet age-related macular degeneration (wAMD), diabetic macular edema (DME) and diabetic retinopathy (DR), solely due to an ongoing review of inspection findings at a third-party filler.
The revelation saw the shares of the drug’s developer, Regeneron Pharmaceuticals (Nasdaq: REGN), fall 8.7% to $716.09 by close of trading yesterday.
Regeneron noted that the CRL did not identify any issues with the aflibercept 8mg clinical efficacy or safety, trial design, labeling or drug substance manufacturing, and no additional clinical data or trials have been requested, and said it is committed to working closely with the FDA and the third-party filler to bring aflibercept 8mg to patients with wAMD, DME and DR as quickly as possible.
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