Regeneron Gets ‘Complete Response’ on Eylea sBLA

FDA has issued Regeneron a complete response letter for its pre-filled Eylea HD syringe supplemental BLA due to unresolved inspection findings at third-party manufacturer Catalent’s troubled Indiana facility. Regeneron now says it plans to submit by 1/2026 an application to include a new pre-filled syringe manufacturing filler for Eylea HD.

The facility, which Novo Nordisk acquired from Catalent 12/2024, has a history of FDA scrutiny that predates the acquisition. The latest inspection, according to a Form FDA-483, identified a range of serious problems, including contamination issues, equipment failures, and testing and controls lapses (see earlier story). Earlier this month, FDA assigned an “Official Action Indicated” classification to the July inspection at the facility.

Regeneron also notes there is another supplemental BLA under review for Eylea HD every-four-week dosing and for treating macular edema following retinal vein occlusion, which has a review action target date of late next month.