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FDA Accepts Roche's Fenebrutinib NDA Under Priority Review For Relapsing And Primary Progressive MS, Backed By Phase III Data Showing 51.1%, 58.5% Relapse Reductions Vs Teriflunomide

Sep 30, 2026 · 02:43 AM ET· updated 1h ago

Fenebrutinib cut relapses by 51% and 58% vs teriflunomide in Phase III RMS trials (FENhance 1 & 2) while showing a consistent, positive trend in delaying disability1Fenebrutinib became the first investigational

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Why It Matters

Roche's new medicine for MS showed it cuts relapses better than current treatments. The FDA fast tracked it, which means the company thinks it could help patients soon.

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Source: Benzinga · Read the original report at the publisher. Headline and figures shown for context; data may be delayed.

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