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Autoimmune-Summaries: Daily Autoimmune Updates at a Glance

  • decodeMR Team
  • Apr 27
  • 1 min read

24/04/2026










Sanofi’s tolebrutinib was recommended for EU approval to treat secondary progressive multiple sclerosis without relapses (Ref)


Sanofi announced that the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion recommending the approval of Cenrifki (tolebrutinib; BTK inhibitor) in the EU for the treatment of secondary progressive multiple sclerosis (SPMS) without relapses in the last two years.


  • The positive CHMP opinion was based on data from the Phase 3, HERCULES/ NCT04411641 study in non-relapsing SPMS, with supporting data from the Phase 3, GEMINI 1/ NCT04410978 and GEMINI 2/ NCT04410991 studies in relapsing multiple sclerosis (RMS)


  • The safety profile of tolebrutinib was consistent across the clinical program.




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