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Roche's Experimental MS Drug Succeeds in Late-Stage Trial
11 Nov
Summary
- Roche's fenebrutinib drug met main goal in relapsing MS trial
- Drug could provide new treatment option and bring over $1B in sales
- Fenebrutinib also effective against primary progressive MS form
As of November 11, 2025, Roche's experimental multiple sclerosis drug fenebrutinib has achieved success in one of two key late-stage trials testing it against the relapsing form of the disease. The drug was shown to significantly reduce the annualized relapse rate when compared to teriflunomide, another MS medication sold under the brand name Aubagio by Sanofi.
If approved, fenebrutinib could provide a new treatment option for MS patients and potentially generate over $1 billion in annual peak sales for Roche, according to analysts. In a separate study, the drug candidate was also found to be at least as effective as Roche's own Ocrevus in delaying the progression of primary progressive multiple sclerosis, another form of the disease.
Roche expects to share detailed data from both the relapsing MS and primary progressive MS studies at an upcoming medical meeting and will submit the findings to regulatory authorities. The company noted that the second late-stage trial against relapsing MS is expected to have results available by the first half of 2026. Earlier this year, the U.S. FDA had temporarily halted enrollment of new patients in this study due to cases of liver injury, but Roche stated that the liver safety profile is consistent with previous trials.
