Sanofi (SNY) recently announced that the US Food and Drug Administration (:FDA) has accepted the marketing application of its type II diabetes candidate, lixisenatide. The company is looking to get lixisenatide approved for the treatment of adults with type II diabetes.
The company submitted the New Drug Application for lixisenatide on the basis of the GetGoal program. The program initiated in May 2008, consisted of 11 trials and enrolled more than 5,000 type II diabetes patients. Lixisenatide demonstrated a promising efficacy and tolerability profile in the trials. Sanofi had in-licensed lixisenatide from Zealand Pharma.
We remind investors that the European Commission (EC) cleared lixisenatide (brand name: Lyxumia in EU) for glycemic control in adults suffering from type II diabetes on Feb 1, 2013. The drug is expected to be launched by the end of the first quarter of 2013.