Regeneron said late Tuesday that the FDA rejected its new, 8-mg version of its blockbuster Eylea (aflibercept) due to an ongoing review of inspection findings at a third-party filler. Regeneron stock shares fell by almost 8% after the announcement.
The complete response letter is a major blow to the New York-based company’s attempt to expand the use of its eye injection for the treatment of patients with wet age-related macular degeneration, diabetic macular edema and diabetic retinopathy. The company also had sought to speed the FDA’s review of this application with a priority review voucher, which typically cost about $100 million.
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