Sanofi pulls lixisenatide’s FDA application

Candace Stuart | | Cardiovascular Business | Structural Heart Disease

Sanofi rescinded its New Drug Application (NDA) with the FDA for lixisenatide, saying the decision was based on concerns about compromising its ELIXA cardiovascular study.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.”

Candace Stuart, Contributor

Related Content

CMS proposes Medicare coverage for transcatheter tricuspid valve replacement
Hydra TAVR valve gains key approval as global reach continues to grow
SAVR outperforms TAVR in patients with bicuspid aortic valves
Treating AFib patients with TAVR still linked to elevated risks
Heart surgeons detail world’s first robotic heart procedure of its kind
Years of progress have made TAVR more effective when treating concomitant mitral stenosis

Around the web

Radiology Business
Key takeaways from RSNA 2024 for AI, CT, MRI and the radiology staffing shortage

Several key trends were evident at the Radiological Society of North America 2024 meeting, including new CT and MR technology and evolving adoption of artificial intelligence.

Health Imaging
Use of AI opportunistic screening in CT for cardiovascular disease

Ron Blankstein, MD, professor of radiology, Harvard Medical School, explains the use of artificial intelligence to detect heart disease in non-cardiac CT exams.

Health Imaging
New imaging protocols proposed to curb rise of cardiovascular infections

Eleven medical societies have signed on to a consensus statement aimed at standardizing imaging for suspected cardiovascular infections.