Novartis' Remibrutinib Shows Promise in Phase 3 Trials for Relapsing Multiple Sclerosis
Novartis' oral BTK inhibitor, remibrutinib, has demonstrated significant efficacy in two Phase 3 trials, REMODEL-1 and REMODEL-2, for the treatment of relapsing multiple sclerosis (RMS). The trials showed that remibrutinib was substantially more effective than Novartis' previous oral MS therapy, Aubagio (teriflunomide), in reducing the annualised relapse rate (ARR), which was the primary endpoint. Additionally, remibrutinib met all key secondary endpoints, including a significant reduction in new MRI lesions and a clinically meaningful delay in disability progression. The safety profile observed in these trials was consistent with previous clinical studies of the drug. Remibrutinib is already approved in the U.S., EU, and Japan for chronic spontaneous urticaria (CSU) under the brand name Rhapsido, and is being investigated for several other immune-mediated and neurological conditions, such as chronic inducible urticaria (CINDU), hidradenitis suppurativa (HS), food allergies, and generalized myasthenia grav...