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Sanofi Says Rilzabrutinib Designated Breakthrough Therapy In US

ReutersFeb 9, 2026 6:04 AM

- Sanofi SA SASY.PA:

  • RILZABRUTINIB DESIGNATED BREAKTHROUGH THERAPY IN US

  • JAPANESE MINISTRY OF HEALTH, LABOUR AND WELFARE HAS ALSO PROVIDED RILZABRUTINIB AN ORPHAN DESIGNATION FOR SAME CONDITION

  • BOTH DESIGNATIONS ARE BASED ON CLINICAL DATA FROM ONGOING LUMINA 2 PHASE 2B STUDY

  • NEW LUMINA 3 PHASE 3 STUDY IS ASSESSING RILZABRUTINIB COMPARED WITH PLACEBO IN PATIENTS WITH WAIHA

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