What is the primary finding for Roche's fenebrutinib in the PPMS trial?

The experimental drug fenebrutinib met its primary goal in a late-stage trial for primary progressive multiple sclerosis (PPMS).

How does fenebrutinib compare to Ocrevus for PPMS patients?

In a Phase III study, fenebrutinib reduced the risk of worsening disability by 12% compared to Roche's Ocrevus, the only approved therapy for PPMS.

When does Roche plan to seek regulatory approval for fenebrutinib?

Roche plans to submit fenebrutinib for regulatory approval in the first half of 2026, once additional Phase III data from a relapsing MS trial is available.

Home / Health / Roche Drug Shows Promise for Rare MS Form

Roche Drug Shows Promise for Rare MS Form

8 Feb

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Summary

Experimental drug fenebrutinib met its primary goal in a key trial.
The drug reduced disability worsening risk by 12% compared to Ocrevus.
Roche expects to submit for regulatory approval in early 2026.

Roche Drug Shows Promise for Rare MS Form

An experimental multiple sclerosis drug from Roche, fenebrutinib, has achieved a significant milestone by meeting its primary goal in a late-stage trial. This trial focused on patients with primary progressive multiple sclerosis (PPMS), a rare and challenging form of the disease.

The Phase III study revealed that fenebrutinib reduced the risk of worsening disability by 12% when directly compared to Ocrevus, Roche's existing treatment for PPMS. The separation of treatment curves was observed as early as 24 weeks, with additional analyses suggesting potential improvements in upper-limb function.

This development is particularly noteworthy as fenebrutinib is the first experimental therapy in over a decade to demonstrate a reduction in disability progression in a PPMS study. Roche has indicated plans to seek regulatory approval for the drug. This submission will occur after the company obtains additional Phase III data from a separate trial involving relapsing MS, which is projected for the first half of 2026.