Novartis MS drug beats standard therapy in two Phase III trials

Novartis ↘ 1.90% announced on Tuesday that its oral BTK inhibitor remibrutinib met the primary endpoint in two Phase III trials in relapsing multiple sclerosis, a result that positions the Swiss drugmaker to file for regulatory approval and strengthens its hand in an increasingly competitive race among next-generation MS therapies.

REMODEL Trials Show Superiority Over Teriflunomide

In the REMODEL-1 and REMODEL-2 trials, remibrutinib demonstrated a statistically superior reduction in annualized relapse rate compared to teriflunomide, an older oral MS therapy, according to a Novartis press release. Nearly 2,000 patients across multiple countries participated in the two multicenter, double-blind studies. Participants with Expanded Disability Status Scale scores ranging from 0.0 to 5.5 were randomized to receive either remibrutinib or teriflunomide.novartis+1

Both trials also showed remibrutinib was superior across key secondary endpoints, including reductions in new MRI lesions. A preplanned combined analysis indicated a positive trend in three-month confirmed disability progression and a nominally statistically significant result for six-month confirmed disability progression. The drug's safety profile was consistent with earlier studies, with no liver safety signal identified and no cases meeting Hy's Law criteria.clinicaltrialsarena+2

"The positive REMODEL results underscore the potential of remibrutinib as a high-efficacy oral therapy for people living with RMS with a differentiated benefit-risk profile," Novartis said.pharmaphorum+1

A Crowded BTK Field

The results arrive amid a broader push by pharmaceutical companies to bring BTK inhibitors into the MS market. Roche ↘ 0.24% earlier this year reported that its BTK inhibitor fenebrutinib showed a 12% reduction in the risk of disability progression compared to ocrelizumab in primary progressive MS, while Sanofi ↘ 0.20% partner tolebrutinib failed to show benefit over placebo in PPMS. Remibrutinib, already approved in the U.S. and EU under the brand name Rhapsido for chronic spontaneous urticaria, is also being studied in secondary progressive MS, hidradenitis suppurativa, food allergies, and myasthenia gravis.stocktitan+3

What Comes Next

Novartis said it plans to file for regulatory approval of remibrutinib in relapsing MS across multiple regions and will present late-breaking data from the REMODEL trials at MSToronto2026. As reported by Pharmaphorum, the positive results bolster remibrutinib's blockbuster credentials across a growing number of indications.clinicaltrialsarena+1