Rilzabrutinib (Wayrilz) will be available on August 29, 2025, for adult patients with persistent or chronic immune thrombocytopenia (ITP) who have not experienced adequate responses to prior therapies.
Mechanism of Action:
Rilzabrutinib is an oral, reversible BTK inhibitor that targets a protein involved in immune cell communication
Clinical Trial Data:
Efficacy- In the phase 3 LUNA study patients treated with rilzabrutinib had a statistically significant durable platelet response compared to placebo. Faster time to the first platelet response was observed in the rilzabrutinib arm. Patients reported significant improvements in health-related quality of life measures
Safety- The most frequent side effects in the study included diarrhea, nausea, headache, and abdominal pain.