Sanofi rescinded its New Drug Application (NDA) with the FDA for lixisenatide, saying the decision was based on concerns about compromising its ELIXA cardiovascular study.
ELIXA (Evaluation of LIXisenatide in Acute coronary syndrome) is evaluating cardiovascular outcomes in patients who recently experienced an acute coronary syndrome event. Lixisenatide is a glucagon-like peptide-1 receptor agonist used to treat patients with type 2 diabetes mellitus. The study was designed to determine if lixisenatide reduces cardiovascular morbidity and mortality compared to placebo in type 2 diabetic patients at high risk of an acute coronary event.
The study is expected to be completed by August 2014. Sanofi reported it would resubmit the NDA in 2015.
According to Paris-based Sanofi, the NDA review process involved early interim results. The company wrote in a release that “the potential public disclosure of early interim results, even with safeguards, could potentially compromise the integrity of the ongoing ELIXA CV study. Sanofi’s decision is not related to safety issues or deficiencies in the NDA.”