Novartis remibrutinib reduces multiple sclerosis relapse rates

Data from two Phase III trials, REMODEL-1 and REMODEL-2, show that Novartis’ oral BTK inhibitor remibrutinib significantly reduces annualized relapse rates (ARR) in adults with relapsing multiple sclerosis. Compared to the active comparator teriflunomide, remibrutinib reduced ARR by 35.2% in the first trial and 31.2% in the second.

While the results demonstrate efficacy and a favorable safety profile with no reported liver safety signals, the reduction fell below analyst expectations, which had projected improvements between 45% and 60%. For comparison, Roche recently reported a 55% reduction in ARR with its rival drug, fenebrutinib.

Novartis intends to seek global regulatory approval for remibrutinib in relapsing multiple sclerosis. The company also utilizes a 25 mg formulation of the drug, known as Rhapsido, which is already approved for chronic spontaneous urticaria in the United States and the European Union.