LixiLan lixisenatide/insulin glargine regulatory update

Sanofi submitted an NDA to FDA along with a Priority Review voucher seeking expedited review of LixiLan to treat Type II diabetes. LixiLan is a combination of Lantus insulin glargine, a synthetic sustained-release subcutaneous insulin analog, and Lyxumia lixisenatide, a glucagon-like peptide-1 receptor ( GLP-1R; GLP1R) agonist. A regulatory submission in the EU is expected this quarter.

The submission triggers a $20 million milestone payment to Zealand under a 2003 deal granting Sanofi exclusive, worldwide rights to develop and commercialize lixisenatide. Zealand is eligible to receive up to $140 million in remaining milestones under the deal (see BioCentury, June 30, 2003). Lixisenatide is approved in Europe to improve glycemic control in adult Type II diabetics. ...