Our Take
This is regulatory approval of a first-in-class drug, not a performance breakthrough—the clinical bar (delay of disability onset) is real but vendor-reported without independent replication.
Why it matters
Secondary progressive MS without relapses has no established disability-targeting treatments; SPMS costs European health systems more annually per patient than average income. Clinicians now have a direct option for the progression-only population.
Do this week
Neurology teams: review Cenrifki's liver-monitoring requirements (drug-induced liver injury is a named safety risk) and enrol eligible nrSPMS patients in Sanofi's Patient Support Program before German launch.
European approval for disability-focused MS therapy
The European Commission approved Sanofi's Cenrifki (tolebrutinib) for adults with secondary progressive multiple sclerosis (SPMS) without relapses in the past two years. The decision follows a positive opinion from the European Medicines Agency's Committee for Medicinal Products for Human Use and rests on results from the HERCULES phase 3 trial in non-relapsing SPMS (nrSPMS), supported by data from the GEMINI 1 and 2 phase 3 studies in relapsing MS.
Cenrifki is an oral, brain-penetrant Bruton's tyrosine kinase inhibitor designed to target smouldering neuroinflammation, the underlying driver of disability progression in progressive MS. The company reports that HERCULES showed Cenrifki significantly delayed the onset of disability progression in nrSPMS (company-reported benchmark, no independent reproduction published). Sanofi will launch Cenrifki commercially in Germany later this year, supported by a Risk Management Program and Patient Support Program.
SPMS without relapses has no established treatment options
Secondary progressive MS is characterised by continuous disability accumulation, often without effective treatment options. The condition can lead to fatigue, cognitive impairment, mobility challenges, and loss of independence. Across major European economies, yearly costs of MS-related disability exceed the average annual income per person, and many patients reduce working hours or leave the workforce entirely (company-reported cost figures).
Until approval, no therapy in the EU was specifically authorised to address the underlying process of disability accumulation in adults with SPMS without relapses. Cenrifki fills that gap, offering clinicians a first direct option for patients with progressive disease and no recent relapse activity.
Safety monitoring is non-negotiable with this agent
Cenrifki's safety profile has been consistent across its clinical programme. The most common adverse events were COVID-19 and upper respiratory tract infections; significant liver enzyme elevations were also observed (company-reported). Drug-induced liver injury is an identified safety risk, and Sanofi has stressed the importance of strict adherence to liver monitoring requirements.
Neurology teams deploying Cenrifki must build liver function monitoring into standard patient review cycles. The company's Risk Management Program and Patient Support Program are designed to support this adherence; early collaboration with local MS specialists and patient-facing teams will be essential during the German rollout to establish protocols before expansion to other European markets.