Sanofi’s experimental drug Cenrifki (tolebrutinib) has been recommended for approval in the European Union by the European Medicines Agency’s CHMP for treating secondary progressive multiple sclerosis (SPMS) without relapses. A final regulatory decision is expected in the coming months.

The recommendation is based on phase 3 trial results showing the drug significantly delayed disability progression in patients, addressing a major unmet need in MS treatment. Cenrifki targets underlying neuroinflammation, a key driver of disease progression.

Sanofi highlighted that the therapy could potentially transform care for patients with limited treatment options, while noting safety considerations including infection risks and liver-related side effects requiring monitoring.