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# CRL for Regeneron Aflibercept BLA
- URL: https://www.fdaweb.com/crl-for-regeneron-aflibercept-bla/
- Published: 2023-07-10T12:00:00.000Z
- Updated: 2026-09-14T18:42:54.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5154826

FDA has issued a complete response letter (CRL) to Regeneron Pharmaceuticals for its BLA for aflibercept 8 mg to treat patients with wet age-related macular degeneration, diabetic macular edema, and diabetic retinopathy. The company [says](https://investor.regeneron.com/news-releases/news-release-details/fda-issues-complete-response-letter-crl-aflibercept-8-mg?ref=fdaweb.com) the issuance of the CRL was due solely to an ongoing review of inspection findings at a third-party filler.

“The CRL did not identify any issues with the aflibercept 8 mg clinical efficacy or safety, trial design, labeling, or drug substance manufacturing, and no additional clinical data or trials have been requested,” Regeneron says.

The company says it is committed to working closely with FDA and the third-party filler to bring aflibercept 8 mg to patients as quickly as possible.