Sanofi: European Green Light for Cenrifki in Progressive Multiple Sclerosis
Sanofi announced on Tuesday the approval by the European Commission of Cenrifki (tolebrutinib) to treat secondary progressive multiple sclerosis (SPMS) without relapses for the past two years. This oral medication positions itself as the first treatment specifically targeting disability progression in this form of the disease.
Approval Based on Demonstrated Slowdown of Disability Progression
The European approval is based on the results of the phase 3 HERCULES study conducted in patients with non-relapsing SPMS (nrSPMS). This study demonstrated that Cenrifki significantly delays the onset of disability progression. The approval also relies on supporting data from the GEMINI 1 and 2 phase 3 studies conducted in patients with relapsing-remitting multiple sclerosis (RMS). Cenrifki functions as an oral Bruton's tyrosine kinase inhibitor, designed to target chronic neuro-inflammation, identified as a key factor in the progression of disability in progressive multiple sclerosis. The treatment is administered once daily during a meal and must be initiated and supervised by a physician experienced in treating the disease.
Safety Profile Requiring Strict Hepatic Monitoring
The safety profile of Cenrifki has proven consistent across the clinical program. The most common adverse events were COVID-19 and upper respiratory tract infections. However, significant increases in liver enzymes were observed, and drug-induced liver injury (DILI) is a recognized safety risk. Sanofi emphasizes that strict adherence to hepatic monitoring requirements and prompt management of increased liver enzymes remain essential to mitigate this risk. The laboratory plans a commercial release of Cenrifki in Germany this year, framed by a robust risk management program and a comprehensive patient support program.
First Treatment Targeting Progression in a Severe Form
SPMS represents a debilitating phase of multiple sclerosis, characterized by a progressive accumulation of disability including fatigue, cognitive disorders, mobility difficulties, and loss of independence, often without available therapeutic options. Sanofi presents Cenrifki as the first therapy specifically designed to treat this underlying process of disability progression in this patient population.
