- Sanofi's experimental diabetes treatment iGlarLixi won the backing of an FDA advisory panel on Wednesday, despite some concerns in a preliminary review of the drug.
- Members of the advisory committee voted 12-2, with one abstention, to recommend approval of the drug, which combines Sanofi's Lantus (insulin glargine) with a GLP-1 agonist called lixisenatide.
- IGlarLixi's positive recommendation comes one day after the panel voted unanimously in favor of a similar drug from Sanofi's diabetes rival Novo Nordisk.
Sanofi's Lantus has been a mainstay treatment for diabetes, bringing in tens of billions for the French pharma giant. But with new competition from drugs like Novo's Tresiba and Lilly/Boehringer's Basaglar, Sanofi has been seeking to shore up its diabetes business with new products.
The company has lined up an immediate successor to Lantus with its next-gen basal insulin Toujeo, which was approved in the U.S. last year.
IGlarLixi, on the other hand, combines Lantus with the GLP-1 receptor lixisenatide agonist to more effectively control glucose levels. Lixisenatide, however, is not yet approved in the U.S., although it is already on the market in Europe.
Panel members were concerned the packaging of iGlarLixi into two doses delivered by two separate injection pens could lead to administration errors, Reuters notes.
But the favorable vote sets up a likely approval for the drug in August. While the FDA is not required to follow the recommendations of its advisory committees, it usually does.
Lixisenatide is under its own FDA review, with a decision date expected in July.