The European Commission has approved Sanofi’s Cenrifki (tolebrutinib) for adults with secondary progressive multiple sclerosis (SPMS) without relapses in the past two years, marking the first EU authorisation for a medicine specifically targeting disability progression in this population.
The decision follows a positive opinion from the European Medicines Agency’s Committee for Medicinal Products for Human Use and is based on results from the HERCULES phase 3 study in non‑relapsing SPMS (nrSPMS), supported by data from the GEMINI 1 and 2 phase 3 studies in relapsing multiple sclerosis. According to Sanofi, HERCULES showed that Cenrifki significantly delayed the onset of disability progression in nrSPMS.
Sanofi said the safety profile of Cenrifki has been consistent across its clinical programme. The most common adverse events were COVID‑19 and upper respiratory tract infections, while significant liver enzyme elevations were also observed.
Drug‑induced liver injury is an identified safety risk and the company stressed the importance of strict adherence to liver monitoring requirements.
Cenrifki will be made commercially available in Germany later this year. Sanofi said this will involve close collaboration between local medical teams, MS specialists and patients, supported by a Risk Management Program and a Patient Support Program.
The company described this as reflecting its commitment to a careful approach to introducing a first‑in‑class medicine for people living with SPMS without relapses.
SPMS is a debilitating stage of MS characterised by continuous accumulation of disability, often without effective treatment options. The condition can lead to fatigue, cognitive impairment, mobility challenges and loss of independence.
Across major European economies, the yearly cost of MS‑related disability exceeds the average annual income per person, with many patients reducing working hours or leaving the workforce entirely.
Cenrifki is an oral, brain‑penetrant Bruton’s tyrosine kinase inhibitor designed to target smouldering neuroinflammation, a key driver of disability progression in MS. It is the first therapy approved in the EU to address the underlying process of disability accumulation in adults with SPMS without relapses.
