India Pharma Outlook Team | Tuesday, 11 November 2025
Roche’s experimental multiple sclerosis (MS) drug fenebrutinib has reached a major milestone, meeting its main goal in one of two late-stage trials for relapsing MS.
The treatment sharply reduced annualised relapse rates over 96 weeks compared with Sanofi’s teriflunomide, sold as Aubagio, the company said on Monday. Roche’s shares rose nearly 2% following the announcement.
If approved, the MS drug fenebrutinib could become a new treatment option for patients and generate more than USD 1 billion in annual peak sales, analysts from Leerink said.
Also Read: India's Path to Billion-Dollar Drugs: Building a Strong Ecosystem
In another study, the therapy was at least as effective as Roche’s own Ocrevus in slowing the progression of primary progressive MS.
The data from the second late-stage relapsing MS trial will be available in the first half of 2026. The U.S. FDA had a brief pause on new patient enrolments in 2023 over liver injury concerns, but Roche confirmed the liver safety results were in line with earlier results.
Fenebrutinib belongs to a newer class of drug, Bruton's tyrosine kinase (BTK) inhibitors, that addresses the immune response driving MS more specifically than older therapies.
Roche said that it will present all the trial results at a future medical meeting and will submit data available for regulatory review. Jefferies analysts said final approval will hinge on all safety and efficacy data reviewed comprehensively over the company's complete development program.
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