FDA Deals Sanofi a Setback in Combo Battle

A $245 million priority review voucher is essentially wasted, not over the therapy, but the delivery device.

Being first matters in Big Pharma, and it appears Sanofi just lost a chance to cross the finish line ahead of Novo Nordisk on the next big thing in diabetes therapy.

Late Friday, Sanofi announced it had submitted updated information to FDA on the pen delivery device that is part of its application for its basal insulin and lixisenatide combination therapy, which won preliminary approval from an advisory panel in 12-2 vote back in May. That same panel unanimously approved Novo Nordisk’s competing combo, of its Tresiba insulin and liraglutide, sold today as Victoza.

According to Sanofi’s statement, the submission means final approval won’t come until November 2016. So, instead of having a month’s lead time on its rival, Sanofi could now be 2 months behind. That means Sanofi used a $245 million priority review to be first with a combination insulin/GLP-1 receptor agonist only to be on essentially the same timeline—and not over the therapy, but the pen.

“Sanofi appreciates the feedback from the FDA on the delivery device and believes that the information submitted will result in an offering that will serve the needs of adults living with type 2 diabetes in the US,” the statement said.

For a time, it looked like delays with FDA might work against Novo Nordisk; delays in getting Tresiba approved meant the combination, known as Xultophy, stayed off the market in the United States, even though it is approved in Europe.

Both drug companies presented new studies on the insulin/glucagon-like peptide-receptor agonists in June at the 76th Scientific Sessions of the American Diabetes Association: Sanofi presented studies that showed its combination, known for years as LixiLan but more recently as iGlarLixi, produced better outcomes than either drug alone, and that patients lost weight.

Novo Nordisk, meanwhile, presented results from the LEADER trial that showed liraglutide has a cardiovascular (CV) benefit—the drug cut CV death risk by 22%. Separate studies on its Tresiba insulin showed those who used it were less likely to have hypoglycemia events.

But given the recent behavior of formulary managers, being first may not be all that counts. Price will matter, too. In recent weeks, component parts of the 2 combinations have been left off key formularies: liraglutide was excluded by Express Scripts, while the insulin Lantus and its successor Toujeo were excluded by CVS Health in favor of a biosimilar that comes on the market in early 2017.