- Sanofi's GLP-1 receptor agonist, lixisenatide, has a solid efficacy portfolio, which was part of the original submission package in 2013. However, Sanofi pulled it from review in order to strengthen the safety data component of the submission.
- Lixisenatide just made it through a rigorous, long-term safety study.
- The five-year safety study included more than 6,000 patients with type 2 diabetes.
When Sanofi chose to pull its lixisenatide submission in 2013, it was not because of a lack of efficacy. As a GLP-1 receptor agonist, in the same class as drugs like Novo's Victoza (iraglutide) and Lilly's Trulicity (dulaglutide), lixisenatide is designed to increase GLP-1 production in order to upregulate production of insulin, while lowering blood sugar and facilitating weight loss.
However, there have been noteworthy safety concerns in this class, including concerns about cardiovascular (CVD) side effects. There have also been a couple of well-publicized FDA rejections of diabetes drugs, including Novo's new insulin, Tresiba (although the agency has since accepted a resubmission for that drug, and a decision is expected by the fall).
The good news: Sanofi's safety study showed that lixisenatide does not increase risk of heart attacks, strokes, or other CVD events, compared with placebo. Moreover, it is not associated with pancreatic cancer or pancreatitis.
Now that safety has been vetted, Sanofi is ready to submit.