CHMP backs Sanofi’s Cenrifki for non-relapsing SPMS
Bottom line
Sanofi said the European Medicines Agency’s Committee for Medicinal Products for Human Use, or CHMP, adopted a positive opinion recommending EU approval of Cenrifki, the brand name for tolebrutinib, for adults with secondary progressive multiple sclerosis without relapses in the last two years. The recommendation, announced April 24, 2026, is based primarily on the phase 3 HERCULES trial in non-relapsing SPMS, with supporting data from the GEMINI 1 and GEMINI 2 studies in relapsing MS. EMA’s product page says the European Commission now decides whether to grant final marketing authorization, a step that typically follows CHMP opinions within about 67 days. (sanofi.com)
Why it matters: While this is a human neurology story rather than a veterinary medicine development, it’s still relevant to animal health professionals tracking large biopharma pipelines, neuroinflammation research, and regulatory momentum around Bruton’s tyrosine kinase inhibitors. Sanofi is positioning tolebrutinib as a brain-penetrant BTK inhibitor aimed at chronic inflammation behind the blood-brain barrier, and the HERCULES data were notable because non-relapsing SPMS has had no approved treatment options in this setting, according to Sanofi and the published trial record. Independent reviewers at ICER said the evidence suggests tolebrutinib slows progression, but they also flagged uncertainty around the balance of benefit and adverse events, especially hepatic safety. (sanofi.com)
What to watch: The next key milestone is the European Commission’s final decision, along with any label details and safety monitoring language, particularly around liver toxicity. (ema.europa.eu)
Sanofi has cleared an important European regulatory step for Cenrifki, its tolebrutinib program in multiple sclerosis. On April 23, 2026, the EMA’s CHMP adopted a positive opinion recommending approval for adults with secondary progressive multiple sclerosis who have not had relapses in the past two years, and Sanofi disclosed the decision publicly on April 24. If the European Commission follows through, Cenrifki would become a new option for a patient population with limited, and in this case potentially no, approved therapies directed at non-relapsing SPMS. (ema.europa.eu)
The recommendation follows a long development path for tolebrutinib, an oral, brain-penetrant BTK inhibitor designed to affect B cells, macrophages, and microglia. Sanofi has argued that this mechanism could address chronic inflammation within the central nervous system, a feature thought to contribute to disability progression even when overt relapses are no longer occurring. Earlier phase 2 work in relapsing MS helped establish the program, and Sanofi later advanced the drug into late-stage studies across progressive and relapsing disease. (ema.europa.eu)
The key evidence behind the CHMP opinion is the phase 3 HERCULES trial, a randomized, double-blind, placebo-controlled study in non-relapsing SPMS. According to the New England Journal of Medicine publication indexed in PubMed, participants were randomized 2:1 to tolebrutinib 60 mg once daily or placebo. Sanofi has previously reported that HERCULES met its primary endpoint by delaying confirmed disability progression, and the company said the CHMP also considered supportive evidence from the phase 3 GEMINI 1 and GEMINI 2 studies in relapsing MS. (pubmed.ncbi.nlm.nih.gov)
Safety remains part of the story. MS Trust’s summary of the HERCULES data said a small proportion of patients receiving tolebrutinib experienced significant liver enzyme elevations, and Sanofi has also acknowledged liver-related adverse events in prior communications, noting that most resolved but that monitoring is important. That safety backdrop helps explain why outside reviewers have taken a measured tone even while recognizing the drug’s clinical promise. (mstrust.org.uk)
One of the clearer external reactions came from the Institute for Clinical and Economic Review. In its 2025 evidence review, ICER said trial data suggest tolebrutinib slows disease progression in non-relapsing SPMS, but it also emphasized uncertainty about the overall balance between efficacy and adverse events. ICER additionally noted that some clinicians may currently hesitate to label patients as having non-relapsing SPMS because there have been no approved disease-modifying therapies for that population, and that the arrival of an effective option could shift diagnosis patterns and treatment discussions. (icer.org)
Why it matters: For veterinary professionals, this is mainly a strategic intelligence item rather than a directly practice-changing one. It highlights how major drug developers are still investing in neuroimmunology, how regulators are weighing benefit against organ-specific safety risks, and how approval in a high-unmet-need population can reshape diagnosis, referral, and monitoring frameworks. For readers in animal health R&D or comparative medicine, the broader takeaway is the continued industry interest in CNS-penetrant immunomodulators and microglial biology, areas that may also inform translational thinking across species. That said, the liver safety signal is a reminder that mechanistic novelty doesn’t remove the need for careful pharmacovigilance. (ema.europa.eu)
What to watch: The immediate next step is the European Commission decision, which EMA says usually follows a CHMP positive opinion within about 67 days. After that, the market will be watching the final EU label, any formal liver monitoring requirements in the product information, and whether Sanofi can convert European momentum into broader regulatory progress after a more complicated US review path disclosed in late 2025. (ema.europa.eu)