Sanofi’s Rilzabrutinib Shows Promising Results in Phase III Trial for Immune Thrombocytopenia (ITP)

Rilzabrutinib Success in Phase III Trial:
Sanofi's rilzabrutinib, a Bruton tyrosine kinase (BTK) inhibitor, has successfully met the primary endpoint in the Phase III LUNA 3 trial for treating immune thrombocytopenia (ITP) in heavily pre-treated patients.

Durable Platelet Response:
The trial demonstrated a durable platelet response, defined as achieving platelet counts of ≥50,000/μL for at least eight out of the last 12 weeks of the 24-week blinded treatment period without rescue therapy.

Patient Population:
The study included patients with primary ITP who had received a median of four prior therapies and had a median baseline platelet count of 15,000/μL.

Regulatory Submissions:
Sanofi plans to file for approval of rilzabrutinib in the US and EU by the end of 2024.

Safety Profile:
The safety profile of rilzabrutinib was consistent with that reported in previous studies, showing an acceptable safety profile with mostly grade 1 or 2 adverse events.

Additional Indications:
Rilzabrutinib is also being studied for other immune-mediated diseases, including asthma, chronic spontaneous urticaria, prurigo nodularis, IgG4-related disease, and warm autoimmune hemolytic anemia.