Sanofi’s Rilzabrutinib Meets Primary Endpoint of the LUNA-3 (P-III) Study for the Treatment of Immune Thrombocytopenia (ITP)
Shots:
- The P-III trial (LUNA 3) evaluated the safety & efficacy of rilzabrutinib (400mg, BID) vs. PBO (12–24 wks. double blinded followed by 28 wks. open label), followed by a safety follow-up of extension period of 4wks.
- The LUNA 3 trial achieved its 1EP, showing a notably greater percentage of patients on rilzabrutinib vs. PBO, a durable platelet response (during the treatment period without rescue therapy, ≥50,000/μL for 8 of 12 wks. of the 24-wks. blinded). 2EPs highlight the possibility that rilzabrutinib will help individuals with persistent and chronic ITP in a clinically significant way
- Later in 2024, detailed results of the study will be presented at a medical congress. Also, in Nov 2020, the US FDA granted rilzabrutinib FTD to treat ITP and also received ODD previously.
Ref: Sanofi | Image: Sanofi
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Disha is a content writer at PharmaShots. She is passionate and curious about recent updates and developments in MedTech and Pharma industry. She covers news related to clinical trial results and updates. She can be contacted at connect@pharmashots.com.
