FDA request delays timeline for Sanofi’s iGlarLixi drug-device combo for diabetes

By Sarah Faulkner

The FDA’s request for more data on the iGlarLixi drug-device combination for treating Type II diabetes pushed the timeline for a decision back 3 months, Sanofi (NYSE:SNY) and Zealand Pharma (CPH:ZEAL) said last week.

Sanofi said August 19 that it submitted a new data package for iGlarLixi, an injection pen designed to deliver a once-daily dose of Sanofi’s Lantus insulin glargine and the lixisenatide drug it licensed from Zealand Pharma.

Sanofi licensed the development and commercialization rights to lixisenatide in 2003, and expanded the deal to include drug-device combinations. The deal involves up to $135 million in milestone payments for Zealand.

Sanofi submitted a new drug application for iGlarLixi in December 2015, spending $245 million to gain priority review, which the FDA granted in February. An advisory panel recommended approval in May, setting the stage for a decision by the end of the summer. The FDA’s request for additional information pushes the decision date back to November 2016.

Despite the delay, Zealand said it’s still confident that the new data will help lead to FDA approval; the delay won’t affect its financial guidance, the company said.

“IGlarLixi is a combination of 2 already FDA-approved diabetes medicines and has in clinical trials demonstrated significant benefits for adults with Type II diabetes,” president & CEO Britt Meelby Jensen said in prepared remarks. “The combination received a convincing positive recommendation for approval by an FDA advisory committee in May, and Sanofi believes that the additional information submitted will result in an offering that will serve the patient needs.”

The delay is a blow to Sanofi’s attempt to get the device to market before a similar device by rival Novo Nordisk (NYSE:NVO) is approved. The FDA is set to deliver a decision on Novo Nordisk’s device, iDeglira/Xultophy, next month.

ZEAL shares are off -9.5% to about $16.65 (DKK 110) since the news broke last week; SNY shares are down -1.6% to $39.13 over the same period.

($1 = DKK 6.60710)