FDA issues CRL for aflibercept 8 mg from Regeneron Pharmaceuticals

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The company announced the Complete Letter Response from the FDA for the Biologics License Application for aflibercept 8 mg is “solely due to an ongoing review of inspection findings at a third-party filler.”

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Regenron Pharmaceuticals announced the US Food and Drug Administration has issued a Complete Response Letter (CRL) for its aflibercept 8 mg

The company stated in a release the Biologics License Application (BLA) for aflibercept 8 mg is for the treatment of patients with wet age-related macular degeneration (wAMD), diabetic macular edema (DME), and diabetic retinopathy (DR). Furthermore, the company stated the CRL is “solely due to an ongoing review of inspection findings at a third-party filler.”¹

The CRL identified no issues with 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 said in a press release.

“Regeneron is committed to working closely with the FDA and the third-party filler to bring aflibercept 8 mg to patients with wAMD, DME, and DR as quickly as possible,” they continued.

Regeneron and Bayer AG have jointly developed aflibercept 8 mg. The exclusive rights to EYLEA (aflibercept) Injection and aflibercept 8 mg belong to Regeneron in the United States. Outside of the US, exclusive marketing rights belong to Bayer and the companies equally share the profits from sales of EYLEA and future sales of aflibercept 8 mg following any regulatory approvals.

Aflibercept 8 mg remains investigational. Its safety and efficacy have not been approved by any regulatory authority thus far. Regulatory filings have been submitted in Europe and Japan for aflibercept 8 mg and are under review. Submissions are forthcoming for additional regulatory authorities across the globe.

Reference:

1. FDA issues complete response letter (CRL) for aflibercept 8 mg biologics license application solely due to an ongoing review of inspection findings at a third-party filler. Regeneron Pharmaceuticals Inc. Accessed June 27, 2023. https://investor.regeneron.com/news-releases/news-release-details/fda-issues-complete-response-letter-crl-aflibercept-8-mg.