On June 23, Sanofi announced that Tolebrutinib (trade name: Cenrifki) has been approved by the European Medicines Agency (EMA) for the treatment of relapse-free secondary progressive multiple sclerosis (SPMS). This drug is the first approved treatment for non-relapsing SPMS and Sanofi's second approved autoimmune BTK inhibitor. Sanofi's first autoimmune BTK inhibitor, Rilzabrutinib (trade name: Wayrilz ), was approved in the US and Europe in 2025.This approval was supported by the Phase III HERCULES study , which included 1131 patients with non-recurrent SPMS .Patients. Results showed that at a median follow-up of 133 weeks, the proportion of patients in the Tolebrutinib (60 mg, once daily) group who had confirmeddisability progression lasting at least 6 months was significantly lower than that inthe placebo group (22.6% vs 30.7%, HR=0.69, P=0.003).Multiple sclerosis (MS) is a chronic, immune-mediated neurodegenerative disease of the central nervous system that can lead to persistent and irreversible disability over time. The accumulation of disability remains a significant unmet medical need in the field of MS. Currently, approved drugs primarily target peripheral B cells and T cells, with limited intervention on the innate immune processes of the central nervous system that drive disability progression . SPMS is a stage of MS where patients no longer experience relapses but disability continues to accumulate, manifesting as fatigue, cognitive impairment, mobility difficulties, and sexual dysfunction.

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