Sanofi Gets Boost as FDA Clears Autoimmune Blood Disorder Drug

Aug. 29, 2025, 9:55 PM UTC

Sanofi’s drug for a rare autoimmune blood disorder won approval in the US, raising the prospect of the medicine becoming a blockbuster.

The drug rilzabrutinib, which will go by the brand name Wayrilz, has been authorized by the US Food and Drug Administration for adults with persistent or chronic immune thrombocytopenia who have had an insufficient response to a previous treatment. The condition, in which the immune system attacks and destroys platelets, can lead to increased bruising and bleeding.

Wayrilz could become a blockbuster medicine in rare disease alone, said Houman Ashrafian, executive vice president of research and ...

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