EU approves Sanofi's Cenrifki as first disability-targeting drug for non-relapsing SPMS

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โดย GlobeNewswire·Read original
Summary · why it matters

The European Commission has approved Sanofi's Cenrifki (tolebrutinib) for the treatment of secondary progressive multiple sclerosis without relapses in the last two years, making it the first disease-targeting therapy designed to address disability accumulation in this patient group. The approval is based on the HERCULES phase 3 study in non-relapsing SPMS, which showed that Cenrifki significantly delayed the onset of disability progression, with supporting data from the GEMINI 1 and GEMINI 2 phase 3 studies in relapsing multiple sclerosis. The most common adverse events were COVID-19 and upper respiratory tract infections, while drug-induced liver injury is an identified safety risk requiring strict liver monitoring. Sanofi plans to launch Cenrifki commercially in Germany this year, supported by a Risk Management Program and a Patient Support Program. Cenrifki is also approved in Australia and the United Arab Emirates for similar SPMS indications.

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EU approval of Cenrifki, a first-in-class drug for non-relapsing SPMS, based on positive phase 3 data.

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