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Regeneron’s CRL For High-Dose Eylea Benefits Roche, Vabysmo

 
• By Joseph Haas

Although the US FDA complete response letter only cites third-party manufacturing issues, analysts say the delayed approval of 8mg Eylea could continue a competitive advantage for Vabysmo into 2024.

Falling behind
FDA delay may cause Regeneron to cede more ground to Roche's Vabysmo • Source: Shutterstock

Regeneron Pharmaceuticals, Inc.’s strategy for competing with Roche Holding AG’s 2022 launch of Vabysmo in multiple ophthalmic disease indications suffered a setback on 27 June as the US Food and Drug Administration issued a complete response letter for its 8mg formulation of Eylea. Regeneron said the CRL referenced only inspection findings at a third-party fill/finish contractor, but analysts differed on how long this could delay approval of the high-dose formulation of Eylea.

With Vabysmo (faricimab) taking market share from Eylea (aflibercept) in wet age-related macular degeneration (wAMD), diabetic macular edema and diabetic retinopathy since its launch in 2022, Regeneron hoped that high-dose Eylea would compete well by offering a longer interval between injections. (Also see "Roche Has Eylea In Its Sights After Farcimab Approval" - Scrip, 31 January, 2022

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