Regeneron Pharmaceuticals Inc. REGN said Tuesday that the U.S. Food and Drug Administration issued a complete response letter for the biologics license application for a higher-dose version of Eylea for treatment of wet age-related macular degeneration, diabetic macular edema, and diabetic retinopathy. The complete response letter, which indicates that the FDA has decided not to approve an application in its present form, was issued solely due to an ongoing review of inspection findings at a third-party filler and did not identify any issues with the treatment’s efficacy or safety, trial design, labeling or manufacturing, Regeneron said in a release Tuesday. “Regeneron is committed to working closely with the FDA and the third-party filler” to bring the treatment to patients as quickly as possible, the company said. No additional clinical data or trials have been requested, the company said. High-dose Eylea, or aflibercept 8 mg, is being jointly developed by Regeneron and Bayer AG. Regeneron shares were down 1.3% Tuesday before being halted in advance of the news.
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