Sanofi achieved positive results from the LUNA 3 phase 3 study demonstrating that rilzabrutinib 400 mg twice daily orally achieved the primary endpoint of durable platelet response in adult patients with persistent or chronic immune thrombocytopenia (ITP). The safety profile of rilzabrutinib was consistent with that reported in previous studies.
 
LUNA 3 study met its primary endpoint demonstrating a significantly higher proportion of patients receiving rilzabrutinib achieved the primary endpoint of durable platelet response versus placebo. Overall, study participants had a median of four prior ITP therapies and a median baseline platelet count of 15,000/μL (normal platelet count levels typically range from 150,000-450,000/μL). Positive results on key secondary endpoints also underscore the potential for rilzabrutinib to deliver clinically meaningful benefits for patients living with persistent and chronic ITP.
 
Rilzabrutinib was granted Fast Track Designation by the U.S. FDA for the treatment of ITP in November 2020 and was previously granted Orphan Drug Designation.
 
ITP is a serious, acquired autoimmune blood disorder characterized by autoantibody-mediated platelet destruction and impaired platelet production, leading to thrombocytopenia (low platelet counts of less than 100,000/μL) and an increased risk of life-threatening bleeding episodes.