Novartis Says Its MS Pill Beat an Existing Oral Drug. The Numbers Aren't out Yet
Novartis said Sept. 1 that two Phase III trials of its experimental pill remibrutinib met their primary goal in relapsing multiple sclerosis, reducing the annualized relapse rate compared with teriflunomide, an approved oral treatment. The company released no figures for the size of that reduction.
The two trials, REMODEL-1 and REMODEL-2, are identical multicenter, randomized, double-blind studies that enrolled about 2,000 patients globally with evidence of recent disease activity, the release says. Patients scored 0.0 to 5.5 on the Expanded Disability Status Scale, a standard measure of MS-related disability, and were assigned 1:1 to 100 mg of remibrutinib or to teriflunomide. The blinded portion runs up to 30 months, followed by an open-label extension of up to five years.
Novartis also says remibrutinib was superior to teriflunomide on all key secondary endpoints within each trial, including a reduction in MRI brain lesions, and that the trials achieved what it calls a clinically meaningful delay in disability progression: a "positive trend" at three months and a "nominally significant" result at six months in a preplanned analysis combining both trials. Those are the company's characterizations of unpublished data.
On safety, the release says remibrutinib was well tolerated and continues to show no liver safety signal, including no cases meeting Hy's Law criteria, a trial threshold for possible serious liver injury. Novartis says that profile is consistent with a development program covering more than 4,500 trial participants across several conditions.
The company said it will present the REMODEL data as a late-breaker at the MSToronto2026 congress and plans to seek regulatory approval for remibrutinib in relapsing MS worldwide. Until then, no numbers have been published for the relapse-rate reduction or the MRI and disability endpoints.
Remibrutinib is an oral drug that blocks Bruton's tyrosine kinase, an enzyme involved in immune-cell signaling. Discovered at Novartis, it is already sold as Rhapsido for chronic spontaneous urticaria, a persistent hives condition; the drug was approved by the FDA in September 2025 and by the European Medicines Agency in April 2026, per the release. Novartis puts the number of people with multiple sclerosis worldwide at nearly 3 million.
