The European Commission (EC) has approved Cenrifki (tolebrutinib) for the treatment of Secondary Progressive Multiple Sclerosis (SPMS) without relapses in the last 2 years. This follows the positive opinion by the European Medicines Agency's Committee for Medicinal Products for Human Use (EMA-CHMP).

The approval is based on results from the HERCULES phase 3 study (clinical study identifier: NCT04411641) in non-relapsing SPMS (nrSPMS), with supporting data from the GEMINI 1 (clinical study identifier: NCT04410978) and GEMINI 2 (clinical study identifier: NCT04410991) phase 3 studies in Relapsing Multiple Sclerosis (RMS). The HERCULES study demonstrated that Cenrifki significantly delayed the onset of disability progression in nrSPMS.

The safety profile of Cenrifki has been consistent across the clinical program. The most common Adverse Events (AEs) were COVID-19 and upper respiratory tract infections. Significant liver enzyme elevations were also observed. Drug-Induced Liver Injury (DILI) is an identified safety risk of Cenrifki. Strict adherence to liver monitoring requirements, and prompt management of liver enzyme elevations, are important to mitigate DILI risk.

Sanofi will make Cenrifki commercially available in Germany this year in close collaboration between local medical teams, treating MS specialists and their patients, all supported by the required Risk Management Program and robust Patient Support Program. This reflects Sanofi’s commitment to a careful approach to introducing this innovative, first-in-class medicine for people living with SPMS without relapses.