FDA Denies Regeneron's BLA for Extended Dosing Intervals for Eylea HD

Regeneron announced that the FDA has issued a complete response letter (CRL) regarding the supplemental Biologics License Application (sBLA) for the addition of extended dosing intervals (up to every 24 weeks) for Eylea HD (aflibercept) Injection 8 mg across all approved indications.

According to Regeneron, the CRL did not identify any issues with the safety or efficacy of Eylea HD in its approved indications and dosing regimens.

"The FDA did not agree with Regeneron’s proposal to add additional extended dosing intervals (greater than every 16 weeks, which is the maximum dosing interval currently indicated in the label). Regeneron is evaluating the FDA’s decision and will determine a path forward in due course," Regeneron stated in a news release.

Eylea HD is approved with dosing intervals from every 8 to 16 weeks for patients with wet age-related macular degeneration (AMD) and diabetic macular edema (DME), and every 8 to 12 weeks for patients with diabetic retinopathy (DR), following 3 initial monthly doses.