Posted by Michael Wonder on 27 Jun 2023
FDA issues complete response letter for aflibercept 8 mg biologics license application solely due to an on-going review of inspection findings at a third-party filler
27 June 2023 - No issues with clinical efficacy or safety, trial design, labeling or drug substance manufacturing were identified in the complete response letter.
Regeneron Pharmaceuticals today announced that the US FDA has issued a complete response letter for the biologics license application for aflibercept 8 mg for the treatment of patients with wet age-related macular degeneration, diabetic macular oedema and diabetic retinopathy, solely due to an on-going review of inspection findings at a third-party filler.
