Novartis has announced positive topline results from its phase 3 trials of remibrutinib in relapsing multiple sclerosis.
Remibrutinib, a highly selective and potent oral Bruton’s tyrosine kinase (BTK) inhibitor, demonstrated superiority versus teriflunomide in reducing annualised relapse rate (ARR) and inflammatory brain lesions with a favourable safety profile.
The results of the trials establish remibrutinib as a BTK inhibitor that achieved significant reductions in annualised relapse rate across two phase 3 trials in adults with relapsing multiple sclerosis (RMS).
Remibrutinib demonstrated clinically meaningful reductions versus teriflunomide in key secondary endpoints related to disability progression, with a positive trend in three-month confirmed disability progression (3mCDP) and nominal significance in six-month confirmed disability progression (6mCDP) in a preplanned combined analysis of the trial.
