Sanofi’s Cenrifki receives approval as the first disability-targeting medicine for secondary progressive multiple sclerosis without relapses

The European Commission has granted approval for Cenrifki in the treatment of secondary progressive multiple sclerosis without relapses in the preceding two years, following a positive opinion from the European Medicines Agency’s Committee for Medicinal Products for Human Use.

The approval draws on findings from the HERCULES Phase 3 study in non-relapsing SPMS, backed by data from the GEMINI 1 and GEMINI 2 Phase 3 studies in relapsing multiple sclerosis. Results from HERCULES showed that Cenrifki produced a statistically significant delay in the onset of disability progression among those with non-relapsing SPMS.

Throughout the clinical programme, Cenrifki’s safety profile remained consistent. COVID-19 and upper respiratory tract infections were the most frequently reported adverse events. Significant liver enzyme elevations were also observed, and drug-induced liver injury has been identified as a recognised safety risk associated with the medicine. Careful adherence to liver monitoring protocols and prompt management of any enzyme elevations are essential steps in reducing this risk.

Sanofi intends to make Cenrifki commercially available in Germany within the current year, working closely with local medical teams, treating MS specialists, and their patients, all within the framework of the required Risk Management Programme and a comprehensive Patient Support Programme. This measured approach reflects Sanofi’s commitment to introducing this first-in-class medicine responsibly for those living with SPMS without relapses.

Secondary progressive multiple sclerosis represents one of the most debilitating stages of the disease, characterised by a relentless accumulation of disability encompassing fatigue, cognitive difficulties, impaired mobility, and a gradual loss of independence, often in the absence of any available treatment. Across the major economies of Europe, the annual cost of MS-related disability exceeds the average yearly income per person. As disability worsens, many patients find themselves compelled to cut back their working hours or step away from employment altogether, while up to 82% of those severely affected by MS depend on informal caregiving, spreading the burden well beyond the individual. Halting or slowing disability progression remains among the most pressing unmet needs across the entire landscape of MS care.

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Related Topics and Keywords

Cenrifki, multiple sclerosi, Sanofi's Cenrifki