Roche’s fenebrutinib is the first BTK inhibitor to receive U.S. FDA filing acceptance in both relapsing and primary progressive multiple sclerosis
NDA FilingfenebrutinibPositive
AI Analysis
Summary
Roche announced FDA acceptance of the NDA for fenebrutinib, a BTK inhibitor for relapsing and primary progressive multiple sclerosis, under priority review based on Phase III FENhance and FENtrepid trial data. This marks the first BTK inhibitor filing in both RMS and PPMS indications.
Clinical Trial Data
Phase
Phase 3
Outcome Details
FDA accepted NDA under priority review
Importance:8/10
Sentiment:
0.80
BTK inhibitormultiple sclerosisFDA filingpriority reviewfirst-in-class
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Published by GlobeNewswire Pharma on September 30, 2026 5:00 AM