EU Approves Cenrifki, Bringing a Rare New Option for Progressive Multiple Sclerosis

For many people with multiple sclerosis, the heaviest moment of the disease may not be a clearly visible relapse, but the gradual loss of physical function in everyday life. The European Commission’s approval of Sanofi’s Cenrifki for adults with non-relapsing secondary progressive multiple sclerosis places the treatment goal precisely on this phase of the disease course, where fewer drugs are available and which is also harder for the outside world to see.

The active substance in Cenrifki is tolebrutinib, and the applicant is Sanofi Winthrop Industrie. The European Medicines Agency’s Committee for Medicinal Products for Human Use adopted a positive opinion on April 23, 2026, recommending approval for its use in multiple sclerosis; this European Commission decision allows the drug to obtain marketing authorization at the EU level.

The boundary of this indication is quite clear: adults with secondary progressive multiple sclerosis who have had no relapses in the past 2 years. In these patients, disease activity often no longer appears as acute attacks, and the clinical issue shifts to the gradual worsening of walking, balance, fine motor skills, or other neurological functions. For that reason, a drug that can affect “confirmed disability progression” carries a different meaning from one that simply reduces relapse rates.

The approval is mainly based on the Phase 3 HERCULES study, with the GEMINI trials serving as supporting data. According to information published by the EMA, compared with placebo, Cenrifki reduced the risk of 6-month confirmed disability progression by 31%; on imaging measures, the adjusted annualized number of new or enlarging T2 hyperintense lesions fell by an average of 38%. These data provide evidence that the drug may slow disease progression, but they remain population-average results and cannot be directly equated with every patient having the same degree of functional preservation.

Safety is an inseparable part of this approval. The EMA said drug-induced liver injury is the most concerning adverse reaction, and elevated liver enzymes are also listed as a common side effect; Sanofi likewise noted that treatment must be accompanied by liver function monitoring. In other words, Cenrifki brings a new therapeutic possibility while also pushing clinical decision-making toward more detailed risk management: who is suitable for treatment, how to monitor, and when to stop the drug will all affect its position in the real world.

Background Context

In recent years, multiple sclerosis treatment has gained a variety of drugs that can reduce relapses and inflammatory activity, but the progressive disease course has always been a more difficult area. When the disease shifts from relapsing-remitting to secondary progressive multiple sclerosis, neurodegeneration, chronic inflammation, and an imbalance in repair may become intertwined, making clinical trials harder to design and efficacy signals more difficult to capture.

Therefore, Cenrifki’s approval should not be interpreted as meaning that treatment for progressive multiple sclerosis has been solved, but rather as a new starting point. It provides an EU-approved drug for a group of patients who previously had limited options, but the real test will begin after launch: whether long-term disability curves can continue to separate, whether liver safety monitoring can be implemented, and how physicians and patients make steady choices between the expectation of slowing degeneration and the risks of treatment.