Sanofi shares results for phase 3 LUNA 3 trial in immune thrombocytopenia
Betsy Goodfellow | April 23, 2024 | News story | Research and Development | Cardiology, Sanofi, clinical trial, thrombocytopenia
Sanofi has announced positive results from its phase 3 LUNA 3 study, which assessed rilzabrutinib 400mg twice daily oral treatment in adult patients with persistent or chronic immune thrombocytopenia (ITP).
The results demonstrate that the drug met its primary endpoint of durable platelet response in this indication, and its safety profile remained consistent with that reported in previous studies. The clinically and statistically significant results were achieved in ‘a population of patients with primary ITP that had been refractory to prior therapy’, according to the company’s press release.
The trial also saw positive results on key secondary endpoints which highlights the drug’s potential to provide meaningful benefits to patients with persistent and chronic ITP.
Houman Ashrafian, executive vice president and head of research and development at Sanofi, commented: “The results of this study reinforce rilzabrutinib’s potential to be a first-in-class oral, reversible BTK inhibitor that can provide clinically meaningful improvements for people living with severe immune-mediated diseases like ITP. These pivotal results are a testament to our commitment and expertise in rare blood diseases and ability to build a portfolio of next-generation small-molecule inhibitors that are both more selective and optimised to deliver robust efficacy and safety outcomes as compared to existing therapies.”
Betsy Goodfellow
Related Content
Sanofi and Regeneron’s Dupixent receives CHMP recommendation for chronic spontaneous urticaria
Sanofi and Regeneron have received a positive opinion from the European Medicines Agency’s (EMA) Committee …
UCB announces first-in-patient trial success for galvokimig in atopic dermatitis
UCB has reported positive early clinical trial results for galvokimig, an investigational therapy for adults …
FDA approves Wegovy for treatment of MASH in adults with liver fibrosis
The US Food and Drug Administration (FDA) has granted accelerated approval for Wegovy (semaglutide) as …
