Sanofi tees up first regulatory filings for rilzabrutinib after ITP study success

2024-04-23

临床结果临床3期并购免疫疗法

Sanofi’s rilzabrutinib met the primary endpoint of a Phase III study in adults with persistent or chronic immune thrombocytopenia (ITP), setting up regulatory filings for the BTK inhibitor later this year. The oral drug – gained through the $3.7-billion purchase of Principia Biopharma – is a key asset in the French drugmaker’s immunology pipeline.

The LUNA 3 trial randomised adult and adolescents with persistent or chronic ITP to receive rilzabrutinib twice daily or placebo. The study’s main goal is durable platelet response, defined as the proportion of participants able to achieve platelet counts at or above 50,000/μL for at least 8 out of the last 12 weeks of the 24-week blinded treatment period in the absence of rescue therapy.

Sanofi said Tuesday that a statistically and clinically significant higher proportion of patients receiving rilzabrutinib achieved the primary endpoint of durable platelet response versus placebo. The company indicated that detailed results will be presented at a medical congress later this year, while the adolescent part of the study is ongoing and still recruiting.

More to follow.

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