Sanofi's MS drug Cenrifki recommended for EU approval
Sanofi's drug Cenrifki (tolebrutinib) has received a positive recommendation from the European Medicines Agency's CHMP for approval in the EU. The medicine is proposed for treating secondary progressive multiple sclerosis without relapses.
Paris – Sanofi announced that its drug Cenrifki (tolebrutinib) has received a positive opinion from the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) recommending its approval in the EU. The recommendation is for the treatment of secondary progressive multiple sclerosis (SPMS) in patients who have not experienced relapses in the last two years.
SPMS is a debilitating stage of multiple sclerosis characterized by continuous accumulation of disability, leading to issues such as fatigue, cognitive impairment, and mobility difficulties. Addressing disability progression remains a significant unmet need in MS care.
The CHMP's positive opinion is based on data from the HERCULES Phase 3 study, which demonstrated that tolebrutinib significantly delayed disability progression in patients with non-relapsing SPMS. Supporting data also comes from studies in relapsing multiple sclerosis. The drug's safety profile has been consistent across its clinical program, with common adverse events including COVID-19 and upper respiratory tract infections. Elevations in liver enzymes were observed, and drug-induced liver injury (DILI) is identified as a safety risk requiring careful monitoring.
Sanofi is awaiting a final decision from the European Medicines Agency in the coming months and has additional submissions under review globally. Cenrifki is an oral, brain-penetrant Bruton's tyrosine kinase inhibitor designed to target neuroinflammation, a key driver of disability progression in MS.