FDA extends review of Sanofi's iGlarLixi

Sanofi (Euronext:SAN; NYSE:SNY) said FDA has extended a review of Type II diabetes therapy iGlarLixi, a fixed ratio combination of Adlyxin lixisenatide and Lantus insulin glargine. Sanofi said the therapy's PDUFA date is now in November; it previously expected a decision this month.

The company said it submitted new information on the therapy's pen delivery device, resulting in a major amendment to the NDA that led to the extended review. ...