FDA Clears Sanofi’s Wayrilz (rilzabrutinib) for Adult ITP; U.S. Launch in September
The U.S. FDA approved Sanofi’s BTK inhibitor Wayrilz (rilzabrutinib) to treat adult persistent or chronic immune thrombocytopenia (ITP) who failed prior therapies—a milestone from Sanofi’s $3.7B Principia acquisition.
Sanofi plans U.S. availability in September 2025, setting a list price of $17,500 per month (actual patient cost will vary by insurance). Analysts forecast $2–5B peak sales as Sanofi broadens its rare disease & immunology portfolio beyond Dupixent. Wayrilz targets BTK to dampen overactive immune signaling, helping raise dangerously low platelet counts in ITP.
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