Roche’s fenebrutinib filing accepted by FDA

30 September 2026

The US Food and Drug Administration (FDA) has accepted the New Drug Application (NDA) under priority review for fenebrutinib, an investigational non-covalent Bruton’s tyrosine kinase (BTK) inhibitor for the treatment of relapsing multiple sclerosis (RMS) and primary progressive multiple sclerosis (PPMS), Swiss pharma giant Roche (ROG: SIX) said.

The filing acceptance is based on data from the comprehensive clinical programme, including the Phase III FENhance 1 and 2 RMS studies and the Phase III FENtrepid PPMS study.

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