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Novartis's oral drug remibrutinib beat teriflunomide (Aubagio) in reducing relapses and slowing disability progression in two late-stage multiple sclerosis trials. The BTK inhibitor also showed a clean liver safety profile — a key differentiator in its drug class. Novartis plans to seek global regulatory approvals and present full data at a Toronto medical conference.
Novartis's oral MS drug remibrutinib has cleared a major hurdle, outperforming Sanofi's teriflunomide (Aubagio) in two late-stage trials — REMODEL-1 and REMODEL-2 — in adult patients with relapsing forms of multiple sclerosis. The drug not only reduced relapse rates more effectively but also delivered clinically meaningful results in slowing disability progression, a critical benchmark for MS therapies.
What sets remibrutinib apart in the crowded BTK inhibitor class is its safety profile. Earlier drugs in the class — including Sanofi's tolebrutinib and Roche's fenebrutinib — have faced regulatory setbacks due to liver toxicity concerns. Remibrutinib showed no liver safety issues in the trials, prompting one UBS analyst to call choosing it over rivals "a no-brainer." Novartis plans to file for global regulatory approvals and present full data at an upcoming Toronto medical conference.
By the Numbers
Why it matters: With competitors stumbling on safety and efficacy, remibrutinib's strong trial results and clean safety record could make it the go-to oral MS therapy — and a cornerstone of Novartis's long-term growth strategy.