Sanofi's Multiple Sclerosis Drug Tolebrutinib Receives Priority Review in US
The U.S. Food and Drug Administration (FDA) has accepted Sanofi's submission for tolebrutinib for priority review. The drug is intended to treat multiple sclerosis and slow disability accumulation.
PARIS – Sanofi announced that the U.S. Food and Drug Administration (FDA) has accepted its regulatory submission for tolebrutinib for priority review. The drug is being evaluated for the treatment of non-relapsing secondary progressive multiple sclerosis (nrSPMS) and to slow disability accumulation independent of relapse activity in adult patients.
The FDA has set a target action date of September 28, 2025, for its decision. A regulatory submission is also under review in the European Union. If approved, tolebrutinib could be the first and only brain-penetrant Bruton's tyrosine kinase (BTK) inhibitor to treat nrSPMS and slow disability progression.
The submissions are supported by results from Phase 3 studies, HERCULES in nrSPMS and GEMINI 1 and 2 in relapsing MS. These studies provide evidence for tolebrutinib's mechanism of targeting "smoldering neuroinflammation," which Sanofi hypothesizes is a key driver of disability accumulation in MS.
Erik Wallström, Global Head of Neurology Development at Sanofi, stated, "The totality of data across our clinical program validates our scientific understanding of smoldering neuroinflammation as a distinct inflammatory process in MS." He added, "The demonstrated ability of tolebrutinib to delay disability by targeting underlying drivers of the disease represents a potential paradigm shift in treating these patients."