Sanofi hopes to broaden diabetes portfolio as FDA accepts lixisenatide submission
- Sanofi's lixiseantide is a once-daily, prandial GLP-1 receptor agonist,which is in the same class as drugs like Novo's Victoza (liraglutide) and Lilly's Trulicity (dulaglutide). The candidate is designed to increase GLP-1 production in order to upregulate production of insulin while lowering blood sugar and facilitating weight loss.
- Although lixisenatide is an investigational product in the U.S., it is marketed in the E.U. under the trade name Lyxumia.
- Sanofi was originally prepared to submit lixisenatide in 2013, but pulled its application in order to complete safety studies. The result was the ELIXA trial, which enrolled more than 6,000 patients with type 2 diabetes.
All things considered, Sanofi's submission dossier for lixisenatide in the U.S. is one well-qualified package. In addition to the ELIXA data, which showed that lixisenatide has CV safety that is non-inferior to placebo, the efficacy data from the phase 3 GetGOAL trial enrolled 5,000 patients and showed positive safety and efficacy outcomes in terms of the effect on HbA1C, post-prandial glucose, and body weight in adults with type 2 diabetes.
In addition to a strong submission package, Sanofi has the added advantage of two years of real-world dosing in patients in the E.U. Sanofi is ramping up to newly bolster its presence in the area of diabetes therapeutics after several disappointing years in diabetes sales.
But the competition is heating up as rivals win approval for their own diabetes meds and the spectre of insulin biosimilars loom. Earlier this week, Sanofi and Eli Lilly settled a dispute over the latter's Lantus biosimilar, agreeing that Basaglar would begin U.S. sales in December 2016.