Sanofi-Aventis Announces Positive Results For Rilzabrutinib In Phase 3 ITP Study

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(RTTNews) - Sanofi-Aventis Groupe announced positive results from the pivotal LUNA 3 phase 3 study of rilzabrutinib in adults with persistent or chronic immune thrombocytopenia (ITP), a rare immune-mediated disease. These results reinforce the efficacy and safety of rilzabrutinib, an oral, reversible, covalent Bruton's tyrosine kinase (BTK) inhibitor, and further support its potential as a first-in-class treatment for ITP.

Platelet response was achieved in 65% of patients receiving rilzabrutinib compared to 33% of patients on placebo. The primary endpoint was met, with rilzabrutinib demonstrating durable platelet response in 23% of ITP adult patients compared to 0% on the placebo arm, as well as key secondary endpoints including reduced bleeding, number of weeks with platelet response, the need for rescue therapy use, and improved physical fatigue and quality of life measures.

Rilzabrutinib significantly reduced the need for rescue therapy by 52% compared to placebo.

The safety profile of rilzabrutinib was consistent with previous studies. The rates of adverse events (AEs) were similar in patients receiving rilzabrutinib and patients receiving placebo; the most common treatment-related AEs for rilzabrutinib were mild/moderate (grade 1/2), including diarrhea (23%), nausea (17%), headache (8%) and abdominal pain (6%).

Rilzabrutinib is currently under regulatory review in the US and the EU, with a US Food and Drug Administration target action date of August 29, 2025.

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