Sanofi Wins FDA Panel’s Backing for Once-Daily Diabetes Combo

  • Panel votes 12-2 that Sanofi’s drug should be approved
  • Medicine would compete with similar Novo Nordisk product

Sanofi’s once-a-day shot for diabetes that combines two drugs should be approved for sale, a group of advisers to the U.S. Food and Drug Administration said.

The FDA advisory panel voted 12-2 at a meeting Wednesday to back the injection for patients with type 2 diabetes. A similar drug from Novo Nordisk A/S also received support from the panel on Tuesday.

The FDA will take the panel’s recommendations into consideration when it decides whether to approve the competing drugs as the companies race to be the first to introduce such a combination treatment to the U.S. market.

Approval of the combination drug is a key part of Sanofi’s strategy to make up for lost sales when its best-selling Lantus faces generic competition in the U.S. starting later this year. Lantus is a long-acting insulin that generated $7.1 billion in sales in 2015 and is paired in Sanofi’s combination shot with a treatment called lixisenatide. That drug mimics the GLP-1 hormone to stimulate insulin production and isn’t yet approved in the U.S.

Novo’s combination drug, based on two treatments approved in the U.S., is already sold in Europe under the Xultophy brand. It combines the long-acting insulin Tresiba with Victoza, which also mimics GLP-1.

One Treatment First

Patients best suited to use Sanofi’s drug already would have tried a long-acting insulin or a GLP-1, panel members said. This was “viewed much more favorably” than the idea of starting patients on two new drugs at once by giving them the combination before they tried the insulin or GLP-1, said Robert Smith, chairman of the panel and a professor at the Warren Alpert Medical School at Brown University.

Some patients use insulin and a GLP-1 separately to treat their diabetes. If the combination drugs are approved, patients could get both treatments in a once-daily shot.

“One shot a day for the rest of your life isn’t a convenience issue,” Robert Ratner, chief science and medical officer for the American Diabetes Association, said before the meeting. “Which are you more likely to do every day for the rest of your life, one shot or two shots? Medicine doesn’t work if it stays in the bottle.”

Pen Device

Kenneth Burman, director of the endocrinology section at MedStar Washington Hospital Center and a panel member who voted against approval, said he did so because of the design of the pen device used to administer the drug, which some in clinical trials perceived as confusing enough to lead to dosing errors. He said the issues with the pen can be worked out between the FDA and Sanofi.

Sanofi has had a rocky time with its diabetes drug unit. The French company stunned investors 18 months ago by predicting lower-than-expected sales for Lantus, which faces generic competition in the U.S. in December. Toujeo, designed to be a successor product to Lantus, is off to a slow start, and Sanofi was forced to exit a collaboration pact on the development of an inhaled insulin because of low demand.

The company said in January that Christophe Kaplan would be its new diabetes head, replacing Pierre Chancel, who worked for the company and its affiliates for decades and helped build Lantus into the world’s best-selling insulin. On Monday, Sanofi announced the departure of Pascale Witz, the executive committee member who headed Sanofi’s diabetes and cardiovascular divisions.

Millions of Patients

Diabetes affects about 29 million people in the U.S. and is the seventh-leading cause of death, according to the National Institutes of Health. About 90 percent to 95 percent of U.S. adults diagnosed with the disease have the type 2 version, which occurs when cells respond poorly to insulin.

Although Sanofi filed for approval three months after Novo, it gained a sped-up FDA review with a voucher purchased for $245 million. It’s estimated the agency will decide whether to approve Sanofi’s shot by Aug. 23 and Novo’s by July 25.

Sanofi’s treatment may generate $574 million in sales in 2020, according to analysts’ estimates compiled by Bloomberg.

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