Sanofi SA (NASDAQ:SNY) secured two regulatory milestones this week, with European authorities approving Cenrifki for non-relapsing secondary progressive multiple sclerosis (nrSPMS) and Japanese regulators authorizing Wayrilz for persistent and chronic immune thrombocytopenia.
European Commission Clears Cenrifki For Non-Relapsing SPMS
The European Commission approved Cenrifki (tolebrutinib) for adults with secondary progressive multiple sclerosis (SPMS) who have not experienced relapses during the previous two years.
The approval was supported primarily by findings from the Phase 3 HERCULES study in non-relapsing SPMS, along with data from the Phase 3 GEMINI 1 and GEMINI 2 studies in relapsing multiple sclerosis.
Results from HERCULES showed that Cenrifki significantly delayed disability progression in patients with non-relapsing SPMS, an area with limited treatment options.
Investigators also observed significant liver enzyme elevations, with drug-induced liver injury identified as a known safety risk.
Sanofi said strict liver monitoring and prompt management of elevated liver enzymes are essential to reducing that risk.
The company plans to launch Cenrifki in Germany later this year.
Liver Safety Concerns Continue To Shadow Cenrifki
In December 2025, the U.S. Food and Drug Administration (FDA) issued a complete response letter for the new drug application of tolebrutinib to treat non-relapsing SPMS in adult patients.
The FDA determined a serious risk of severe drug-induced liver injury (DILI) identified during clinical trials and noted that the proposed risk evaluation and mitigation strategy could not adequately mitigate the risk.
The Wall Street Journal noted that Sanofi booked a 1.66 billion-euro ($1.90 billion) write-down on tolebrutinib alongside its 2025 results, citing a reduced probability of approval in light of negative results in a late-stage clinical trial for a different type of MS and its interactions with U.S. and EU drug regulators.
Japan Authorizes Wayrilz For Persistent Or Chronic ITP
Separately, Japan’s Ministry of Health, Labor and Welfare granted marketing and manufacturing authorization for Wayrilz (rilzabrutinib), an oral reversible Bruton’s tyrosine kinase inhibitor, for persistent or chronic immune thrombocytopenia (ITP) who have not responded adequately to existing therapies or cannot tolerate them.
The approval was based on data from the Phase 3 LUNA 3 trial, which met both primary and secondary endpoints.
Phase 3 Data Supported Wayrilz Approval In Japan
In the study involving 202 adults with persistent or chronic ITP, 23% of patients receiving Wayrilz achieved a durable platelet response at week 25, compared with none in the placebo group.
Patients treated with Wayrilz also experienced a faster time to first platelet response, reaching response in 36 days compared with no median response reached in the placebo arm.
The treatment additionally produced a longer duration of platelet response, averaging seven weeks versus 0.7 weeks with placebo.
SNY Stock Price Activity: Sanofi shares were up 0.01% at $41.78 at the time of publication on Tuesday, according to Benzinga Pro data.
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