The FDA issued a complete response letter for the biologics license application for aflibercept 8 mg for the treatment of wet age-related macular degeneration, diabetic macular edema and diabetic retinopathy, according to a press release.
The letter did not note any issues with clinical efficacy or safety, trial design, labeling or drug substance manufacturing, and the rejection is “solely due to an ongoing review of inspection findings at a third-party filler,” Regeneron said in the release.
The FDA did not request any additional clinical data or trials.
“Regeneron is committed to working closely with the FDA and the third-party filler to bring aflibercept 8 mg to patients with [wet] AMD, DME and DR as quickly as possible,” according to the release.