- Regeneron Pharmaceuticals (REGN, Financial) received a Complete Response Letter (CRL) from the FDA for EYLEA HD® (aflibercept) Injection 8 mg.
- The FDA rejected the proposed extended dosing intervals beyond the current maximum of 16 weeks.
- EYLEA HD remains approved for existing dosing intervals of 8 to 16 weeks for wAMD and DME, and 8 to 12 weeks for DR.
Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) announced that the U.S. Food and Drug Administration (FDA) has issued a Complete Response Letter (CRL) in response to their supplemental Biologics License Application for EYLEA HD® (aflibercept) Injection 8 mg regarding extended dosing intervals. The proposed application sought to increase dosing intervals up to 24 weeks for all approved indications.
The FDA's decision highlights that no safety or efficacy issues were found with EYLEA HD's current approved indications and dosing regimens. However, the request to extend dosing intervals beyond the maximum 16 weeks was not approved. Regeneron is currently assessing the FDA's decision to determine their next course of action.
EYLEA HD maintains its current approval for dosing intervals of every 8 to 16 weeks for patients with wet age-related macular degeneration (wAMD) and diabetic macular edema (DME), and every 8 to 12 weeks for patients with diabetic retinopathy (DR), after three initial monthly doses.
Regeneron and Bayer AG jointly developed EYLEA HD, with Regeneron retaining exclusive rights in the U.S. while Bayer has licensed marketing rights outside the U.S. As Regeneron continues to innovate within the field of ophthalmology, their commitment remains steadfast in addressing various vision-threatening conditions.
