Sanofi announced on Sunday that its combination diabetes therapy, LixiLan, achieved its primary endpoints in two pivotal phase 3 studies. LixiLan, which comprises basal insulin Lantus and the GLP-1 drug lixisenatide, is a single injection designed to treat type 2 diabetes.
Participants in both studies were type 2 diabetes patients who were unable to control their blood sugar levels with metformin or metformin in conjunction with another add-on drug, wrote FiercePharma. Metformin treatment regimens were continued during the process.
The first study, labeled LixiLan-O, focused on comparing the efficacy of the combination product against its core ingredients over a 30-week period with 1,170 patients. Results demonstrated that LixiLan substantially reduced A1C levels by 1.6 percent whereas Lantus lowered it by 1.3, and lixisenatide only hit 0.9 percent.
The second trial, labeled LixiLan-L, yielded similar results with a smaller margin. The combination drug delivered an A1C reduction of 1.1 percent while the Lantus arm only lowered A1C by 0.6 percent.
Both trials reported similar adverse events like nausea and vomiting, added FiercePharma, although hypoglycemia rates varied.
Sanofi unveiled these results at the annual American Diabetes Association meeting in New Orleanswhere the company noted the data will be included in U.S. and European regulatory submissions.
The French drug maker expects to have LixiLan approved in the U.S. this August followed by a first-quarter approval in Europe next year, according to Reuters.
LixiLan sales are projected to reach an approximate $1 billion in 2020.
Filed Under: Drug Discovery
