Sanofi’s Cenrifki recommended for EU approval to treat non-relapsing secondary progressive multiple sclerosis

The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion recommending approval of Sanofi’s Cenrifki (tolebrutinib) for the treatment of secondary progressive multiple sclerosis (SPMS) without relapses in the last two years. A final European Commission decision is expected in the coming months.

SPMS is a debilitating stage of multiple sclerosis in which patients experience continuous accumulation of disability, including fatigue, cognitive impairment, mobility difficulties and loss of independence, often with no available treatment options. Addressing disability progression in this population remains one of the most significant unmet needs in MS care.

The positive opinion is based primarily on data from the HERCULES Phase 3 study in non-relapsing SPMS, with supporting data from the GEMINI 1 and GEMINI 2 Phase 3 studies in relapsing multiple sclerosis. Results were presented at the ECTRIMS Conference 2024 and the American Academy of Neurology Annual Meeting in 2025, and published in the New England Journal of Medicine. The HERCULES study demonstrated that the brain-penetrant therapy significantly delayed the onset of disability progression in non-relapsing SPMS.

The safety profile of Cenrifki has been consistent across the clinical programme. The most common adverse events were COVID-19 and upper respiratory tract infections. Significant liver enzyme elevations were also observed, and drug-induced liver injury is an identified safety risk. Strict adherence to liver monitoring requirements and prompt management of enzyme elevations are considered important to mitigate this risk.

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Related Topics and Keywords

Cenrifki, eu approval, FDA Approval, multiple sclerosis, non-relapsing secondary progressive multiple sclerosis, Phase 3 trial, Sanofi, Sanofi's Cenrifki