Novartis is planning to file for remibrutinib’s expanded approval in relapsing multiple sclerosis by next year, putting it just behind Roche’s own BTK inhibitor fenebrutinib.
Novartis’ investigational BTK inhibitor remibrutinib, approved last September as Rhapsido for chronic spontaneous urticaria, reduced relapse and disease progression in two late-stage studies of relapsing multiple sclerosis. The positive results set the pharma up for an FDA filing next year and a potential face-off against Roche, which is nearing the market with its own BTK asset.
Topline results from Novartis’ Phase 3 REMODEL-1 and REMODEL-2 studies, disclosed Tuesday morning, showed that patients on remibrutinib had lower annualized relapse rates than comparators on an active control, the multiple sclerosis (MS) drug teriflunomide. The drug is marketed by Sanofi Genzyme as Aubagio but is now available in generic form. Novartis’ drug also resulted in stronger reductions in inflammatory brain lesions.
Remibrutinib likewise showed benefit on key secondary endpoints, including the progression of disability at three and six months, as per a pooled analysis of the two trials. Novartis did not provide specific numbers on the rate of improvement.
“Remibrutinib is now the second BTK inhibitor to achieve nominal statistical significance in [disease progression] compared to teriflunomide” in pooled populations of relapsed MS patients, William Blair told investors in a Tuesday note. The other BTK inhibitor to hit this mark, the analysts said, is Roche’s fenebrutinib.
At the 2026 meeting of the American Academy of Neurology in April, Roche touted a “numerical reduction” in scores on a scale that measures disease progression in patients who were given fenebrutinib, as compared with teriflunomide. At the time, the pharma also reported significant reductions in relapse rates and biomarkers of inflammation for fenebrutinib.
Novartis on Tuesday didn’t provide specific data from the REMODEL trials but promised to do so at an upcoming medical meeting. “We view upcoming presentation of the REMODEL datasets as important to assessing [remibrutinib’s] competitiveness with fenebrutinib,” William Blair said on Tuesday.
Novartis is planning to seek regulatory approval for remibrutinib for relapsing MS globally, slated for next year. Roche is likewise seeking clearance for fenebrutinib, with a filing planned for this year.
Safety is likely to emerge as a key front in the battle between these two drugs, according to William Blair. “We expect comparison of remibrutinib and fenebrutinib’s safety profile to be scrutinized,” the analysts said, particularly as the BTK inhibitor class continues to be hounded by liver safety questions.
In late 2023, the FDA placed a partial clinical hold on fenebrutinib, citing cases of liver injury. It is unclear when the pause was lifted, but Roche has since continued development.
Sanofi had also been advancing a BTK inhibitor, dubbed tolebrutinib, for MS—and has similarly been tripped up by safety issues. Cases of drug-induced liver injury prompted the FDA in mid-2022 to temporarily pause several Phase 3 trials for the drug. More recently, tolebrutinib in December 2025 failed a Phase 3 trial in primary progressive MS, forcing Sanofi to abandon regulatory aspirations in this subtype of the disease. The asset is no longer listed on Sanofi’s pipeline.
Of note, Novartis on Tuesday emphasized that remibrutinib showed no concerning liver signals in the REMODEL studies.
