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FDA priority review of Regeneron’s aflibercept 8mg held up by FDA Complete Response Letter

Jun 27, 2023

Regeneron announced that the FDA has issued a Complete Response Letter (CRL) in relation to the Regeneron BLA for aflibercept 8 mg.  Aflibercept 8mg is being jointly developed by Regeneron and Bayer AG as a higher dose formulation of aflibercept (compared to the currently approved 2mg Eylea®) with the aim of extending treatment intervals.

Regeneron reported that the CRL was issued in relation to inspection findings at a third-party filler, and that no issues with clinical efficacy or safety, trial design, labeling or drug substance manufacturing were identified in the CRL.  Regeneron reported that it will work with the FDA and the third-party filler to obtain approval as soon as possible.

The BLA for aflibercept 8mg for was accepted by the FDA for priority review in February 2023, and has not yet been approved by any regulatory authority.