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Roche Drug Shows Promise for Rare MS Form
8 Feb
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.
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.
