Bloomberg reported that the Complete Response Letter (CRL) issued by the FDA in relation to Regeneron’s BLA for aflibercept 8mg identified deficiencies at Catalent Inc.’s facility in Bloomington, Indiana. On 27 June 2023, Regeneron announced that that the FDA had issued a CRL 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.
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.