Novartis has strong Phase 3 results for an oral multiple sclerosis (MS) pill, remibrutinib — and the data may ease a safety worry that has hampered its entire drug class.
In two large Phase 3 trials in relapsing MS, remibrutinib — a BTK inhibitor already approved for chronic hives — showed superiority over Aubagio (teriflunomide), a widely used oral MS drug, by reducing annual relapse rates and inflammatory brain lesions, with a “clinically meaningful” effect on disability progression. Novartis shares rose more than 4% on the news.
The safety angle
Crucially, remibrutinib wasn’t associated with the liver-related side effects that other BTK inhibitors in MS have run into — a problem that has stalled or sunk competing drugs. Addressing that concern could set remibrutinib apart in a crowded race to bring BTK inhibitors to MS.
Why it matters
BTK inhibitors work inside both immune B cells and the brain’s resident immune cells, and are seen as a promising next step for MS — potentially targeting the smoldering inflammation behind disability, not just relapses. Novartis plans to take the results to regulators; analysts project peak MS sales could exceed $3 billion. These are topline results; full data and any approval decision are still to come.