Sanofi’s Cenrifki (tolebrutinib) has been approved by the European Commission to treat secondary progressive multiple sclerosis (SPMS) without relapses in the last two years. This follows the positive opinion by the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP).
The approval is based on results from the HERCULES phase 3 study non-relapsing SPMS (nrSPMS), with supporting data from the GEMINI 1 and GEMINI 2 phase 3 studies in relapsing multiple sclerosis (RMS).
HERCULES was a double-blind, randomised phase 3 clinical study evaluating the efficacy and safety of Cenrifki in patients with nrSPMS. Participants were randomised to receive either an oral daily dose of Cenrifki or matching placebo for up to approximately 48 months. The study showed that Cenrifki significantly delayed the onset of disability progression in nrSPMS.
Cenrifki is an oral, brain-penetrant Bruton’s tyrosine kinase inhibitor specifically designed to target smoldering neuroinflammation, a key driver of disability progression in MS. This unique mechanism of action addresses the underlying biology of progressive MS by targeting the inflammatory processes that contribute to disability accumulation.
SPMS is a debilitating stage of MS where patients experience continuous accumulation of disability, including fatigue, cognitive impairment, mobility difficulties and loss of independence – often without available treatment options.
Across major European economies, the yearly cost of MS-related disability surpasses the average annual income per person. As disability accumulates, many are forced to reduce working hours or leave the workforce entirely – while up to 82% of those living with severe MS rely on informal caregiving, extending the strain far beyond the individual.
Addressing disability progression remains one of the most significant unmet needs in MS care. Cenrifki is the first disease-targeting therapy designed to address the underlying process of MS disability accumulation approved in the EU for adults with SPMS without relapses in the last two years.