- LixiLan combines the GLP-1 agonist lixisenatide with Lantus, Sanofi's top-selling insulin.
- The target endpoint was to see if LixiLan could lower blood glucose (BG) than the each of the contituent parts of this combo drugs could independently. In addition, the overall safety profile remained intact.
- Novo Nordisk is working on a combo drug with a similar intended effect. Xultophy, which is already approved in the E.U., combines its GLP drug Victoza (liraglutide) with its long-lasting insulin Tresiba—which lasts longer than Lantus.
It seems like an even race—two companies with strong diabetes franchises exploiting the synergies of two potent classes of type 2 diabetes treatments; however, Sanofi now has the upper hand, becaue Novo's Tresiba was rejected by the FDA in 2013. In order to go after an approval for Xultophy in the U.S., Sanofi first has to get Tresiba approved—something the company hopes will happen by winter 2015.
Although Sanofi's combo product is in the lead in the U.S. market, it is facing its own regulatory hurdles with lixisenatide. After Tresiba was rejected, Sanofi pulled its application for lixisenatide; however, last month, Sanofi unveiled five-year results confirming lixisenatide's safe cardiovascular profile. They will be resubmitting the drug this quarter.
Nonetheless, as all of this plays out, the competitive landscape for type 2 diabetes has become more challenging, with Victoza becoming a $2 billion-per-year drug, and other GLP-1 agonists, such as Lilly's Trulicity gaining ground. Given the increasingly epidemic nature of type 2 diabetes, having more treatment options should be considered a good thing.