FDA accepts Roche’s fenebrutinib NDA under priority review for RMS and PPMS

On 30 September 2026, Roche announced that the U.S. Food and Drug Administration (FDA) accepted its new drug application (NDA) under priority review for the oral non-covalent BTK inhibitor fenebrutinib for relapsing MS (RMS) and primary progressive MS (PPMS) — the first BTK inhibitor with U.S. filing acceptance in both, according to Roche and NeurologyLive.

Phase III data cited

The filing is supported by Phase III FENhance 1/2 (versus teriflunomide) and FENtrepid (versus Ocrevus / ocrelizumab). Roche reported annualized relapse rate reductions of 51.1% (p<0.001) and 58.5% (p<0.00001) versus teriflunomide over 96 weeks. FENtrepid met non-inferiority versus Ocrevus on cCDP12 (HR 0.88; 95% CI 0.75–1.03) — the confidence interval crosses 1, so the numerical 12% risk reduction was not statistically superior. Roche reported serious adverse-event rates in RMS arms, liver-enzyme elevations, and an imbalance in reported fatalities across studies with varied causes and timepoints; the company described the safety profile as manageable in more than 2700 participants.

Study type and limitations — read carefully

Acceptance of an NDA is not approval. Efficacy and safety claims come from company-reported Phase III programmes summarised in the Roche release and secondary coverage. This article is not personal medical advice — MS treatment decisions belong with a neurologist and the patient.