Sanofi has pulled back the application to market its diabetes drug lixisenatide in the USA, while it waits to collect all data from an ongoing data from a cardiovascular outcomes trial.
The French drugmaker said it would refile the drug in 2015, following completion of the 6,000-patient ELIXA CV study, to provide the US Food and Drug Administration with a complete set of data to evaluate in one go.
According to Sanofi, the decision follows discussions with the US regulator and its belief that potential public disclosure of early interim data, even with safeguards, could compromise the integrity of the ongoing study.
The move is not related to any safety issues or problems with the application, it stressed, and noted that a combination of lixisenatide and Lantus (basal insulin) remains on schedule to enter into Phase III in the first half of 2014.
Nevertheless, shares in Sanofi slipped near 2% on the news, while those of its partner, Danish drugmaker Zealand Pharma, plummeted 20% as investors absorbed the drug’s delay in this all-important market.
Lixisenatide is approved in Europe as Lyxumia for the treatment of adults with type 2 diabetes mellitus to achieve glycemic control in combination with oral glucose-lowering medicinal products and/or basal insulin when these, together with diet and exercise, do not provide adequate control. The drug has also been cleared in Mexico, Australia and Japan.
