FDA Postpones Decision on Sanofi’s Diabetes Combination Candidate

The FDA is delaying its decision on Sanofi’s Type 2 diabetes therapy IGlarLixi, requesting additional information on its pen injector.

The postponement extends the agency’s review by three months and hampers the company’s efforts to be the first to market a fixed-dose product in the country.

The announcement comes as a significant blow for Sanofi, which purchased a $245 million priority review voucher to outpace Novo Nordisk, the drugmaker behind an insulin and GLP-1 agonist combination of IDeglira and Xultophy.