(Boursier.com) — Positive results from the phase III LUNA 3 study show that taking rilzabrutinib 400 mg twice daily allowed adult patients with persistent or chronic immune thrombocytopenia (IPT) to obtain a durable platelet response – which corresponds to the primary endpoint of the study. The safety profile of rilzabrutinib was consistent with that observed in previous studies.
The LUNA 3 study met its primary endpoint and demonstrated that a significantly greater proportion of patients treated with rilzabrutinib experienced a durable platelet response (the primary endpoint), compared to placebo. This clinically and statistically significant result was obtained in patients with primary IPT who had been refractory to other previous treatments.
The US Food and Drug Administration (FDA) granted Fast Track Designation to rilzabrutinib for the treatment of IPT in November 2020, after granting it orphan drug designation.
Houman Ashrafian, Executive Vice President, Head, Research and Development at Sanofi comments: “The results of this study demonstrate that rilzabrutinib has the potential to become the first oral BTK inhibitor in its pharmacotherapeutic class and to provide clinically important improvements to the treatment of people with serious immune diseases such as IPT The results of this pivotal study demonstrate our commitment and expertise in the field of rare blood diseases and our ability to build a portfolio of small molecule inhibitors. next-generation drugs that are both more selective and optimized to provide strong safety and efficacy results compared to existing drugs.”
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