FDA Accepts Roche’s Fenebrutinib Application for Multiple Sclerosis

The U.S. Food and Drug Administration accepted Roche’s New Drug Application for fenebrutinib under priority review for both relapsing multiple sclerosis and primary progressive multiple sclerosis on 30 September 2026.

According to Roche, fenebrutinib is an investigational oral medication designed as a non-covalent, reversible Bruton’s tyrosine kinase inhibitor intended for use in these two forms of multiple sclerosis.

The FDA’s acceptance of the application under priority review indicates that the submission was considered sufficiently complete to undergo a substantive evaluation process. The application includes data from multiple Phase III clinical studies in both relapsing and primary progressive forms of the disease.

In the Phase III FENhance 1 and 2 studies, fenebrutinib was tested in patients with relapsing multiple sclerosis. Results from these studies showed that fenebrutinib reduced the annualized relapse rate by approximately 51% and 58% compared to teriflunomide over a period of 96 weeks.

What the numbers show

• FDA accepted the application on 30 September 2026.
• Fenebrutinib reduced relapse rates by 51% and 58% in RMS trials.
• 12% reduction in risk of disability progression observed in PPMS study.

For primary progressive multiple sclerosis, the Phase III FENtrepid study evaluated fenebrutinib against Ocrevus. The study met its primary endpoint of non-inferiority, with a numerical 12% reduction in the risk of disability progression, as measured by a hazard ratio of 0.88 and a confidence interval of 0.75 to 1.03.

Fenebrutinib’s application to the FDA includes data from both relapsing and primary progressive multiple sclerosis populations, reflecting the drug’s intended use across these patient groups. The priority review status is reserved for therapies that may offer improvements over existing treatments.

The FDA’s review process will focus on the safety and efficacy data submitted by Roche, including outcomes from the FENhance and FENtrepid clinical trials. The agency’s decision to accept the application under priority review initiates a formal evaluation period.

Roche stated that fenebrutinib remains investigational and is not yet approved for use in any country. The company continues to provide updates as the regulatory process advances.

* This article is based on publicly available information at the time of writing.