Updated: FDA rejects higher dose of Regeneron's Eylea after inspection at contractor Catalent
Regeneron’s new 8 mg version of its blockbuster drug Eylea was rejected by the FDA because of an ongoing review of inspection findings at the third-party manufacturer Catalent.
The complete response letter was disclosed by Regeneron Tuesday and is a major blow to the New York-based company’s attempt to expand use of its eye injection for patients with wet age-related macular degeneration, diabetic macular edema and diabetic retinopathy. Regeneron had sought to speed the FDA’s review with a priority review voucher, which typically costs about $100 million.
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