French healthcare company Sanofi S.A. (Euronext Paris:SAN) (Nasdaq:SNY) reported on Tuesday that the European Commission has approved Cenrifki (tolebrutinib) for the treatment of secondary progressive multiple sclerosis (SPMS) without relapses in the last two years.

This decision follows a positive opinion from the European Medicines Agency's Committee for Medicinal Products for Human Use.

The therapy is positioned as the first disability-targeting medicine for this patient population.

Approval was based on the Phase 3 HERCULES study in non-relapsing SPMS (nrSPMS), supported by data from the GEMINI 1 and GEMINI 2 Phase 3 studies in relapsing multiple sclerosis. HERCULES demonstrated that Cenrifki significantly delayed the onset of disability progression in patients with nrSPMS.

Safety profile was consistent across the clinical programme, with the most common adverse events including COVID-19 and upper respiratory tract infections, while significant liver enzyme elevations and drug-induced liver injury were highlighted as risks requiring strict liver monitoring and prompt management.

Sanofi plans to launch Cenrifki in Germany this year with support from local medical teams, multiple sclerosis specialists, a Risk Management Program, and a Patient Support Program.

Secondary progressive multiple sclerosis is a debilitating stage of the disease characterised by continuous disability accumulation, including fatigue, cognitive impairment, mobility difficulties, and loss of independence, often without available treatment options.