PARIS, April 24, 2026

Sanofi has achieved a significant regulatory milestone as the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) issued a positive recommendation for approval of Cenrifki (tolebrutinib) for treating secondary progressive multiple sclerosis (SPMS) without relapses. This development represents a major breakthrough in addressing one of the most challenging stages of multiple sclerosis, where patients experience gradual and irreversible disability progression with limited treatment options. The recommendation is expected to lead to a final European Union approval decision in the coming months, potentially transforming care standards for patients suffering from progressive neurological decline.

Phase 3 Evidence Demonstrates Delayed Disability Progression

The CHMP recommendation is primarily supported by data from the HERCULES Phase 3 clinical trial, which demonstrated that Cenrifki significantly delayed disability progression in patients with non-relapsing SPMS, a population with high unmet medical need. Additional supportive data from the GEMINI 1 and GEMINI 2 Phase 3 trials further reinforced the therapy’s clinical value across broader multiple sclerosis populations. SPMS is characterized by progressive neurological deterioration, including mobility impairment, cognitive decline, fatigue, and loss of independence, making effective intervention critical.

Cenrifki’s ability to target smoldering neuroinflammation, a key driver of disease progression, positions it as a first-in-class therapeutic approach capable of addressing the underlying pathology rather than just managing symptoms. These findings highlight the potential for Cenrifki to become a cornerstone treatment in progressive MS care, significantly improving long-term patient outcomes.

Innovative Mechanism Targeting Neuroinflammation

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Cenrifki (tolebrutinib) is an oral, brain-penetrant Bruton’s tyrosine kinase (BTK) inhibitor specifically designed to cross the blood-brain barrier and directly target chronic neuroinflammation within the central nervous system. This mechanism differentiates it from many existing therapies that primarily act on peripheral immune activity. By addressing persistent inflammation within the brain, Cenrifki aims to slow or halt disease progression at its source, offering a more precise and durable therapeutic effect.

The safety profile observed across clinical studies has been generally consistent, with common adverse events including COVID-19 infections and upper respiratory tract infections, while liver enzyme elevations and potential drug-induced liver injury (DILI) have been identified as important risks requiring monitoring. Despite these considerations, the overall benefit-risk profile remains favorable, supporting its advancement toward regulatory approval.

Expanding Neurology Pipeline and Future Outlook

This recommendation underscores Sanofi’s broader strategy to advance innovative treatments in neurology and immunoscience, particularly in areas with significant unmet clinical need. The company continues to invest heavily in next-generation therapies targeting neurodegenerative and neuroinflammatory diseases, including Alzheimer’s disease, Parkinson’s disease, and other chronic neurological conditions. Cenrifki represents a critical addition to Sanofi’s late-stage pipeline, reflecting its commitment to delivering transformative therapies that go beyond symptom control to address disease progression.

If approved, Cenrifki could become one of the first therapies specifically indicated for non-relapsing SPMS, setting a new benchmark for treatment standards and improving quality of life for thousands of patients across Europe. The anticipated approval also signals continued momentum in precision neurology, where targeted mechanisms are increasingly reshaping treatment paradigms.

Source: Sanofi press release