FDA questions on Sanofi’s diabetes combo delivery device delays decision

Questions by U.S. regulators regarding the Sanofi device designed to deliver its Lantus-plus-lixisenatide combo to combat diabetes has pushed an approval decision back by three months.

Last week, the FDA requested more data on the dual-drug delivery pen. That means the agency will take a little longer to review the information, and probably won’t make a decision until November. 

Back in May, agency staff voiced concerns about the usefulness of the company’s diabetes treatment that combines two medications. They also questioned results of clinical trials designed to show the therapy is superior to insulin alone.

The dosing mechanism of the combined product might expose some patients to ineffective amounts of Lyxumia, one of the two drugs in the therapy, the staffers said in a May report.

Sanofi spent $245 million to buy a priority review voucher from Retrophin to better its chances to get to market with the its diabetes combo before Novo Nordisk ($NVO) does with its diabetes duo that pairs its basal insulin Tresiba with the GLP-1 blockbuster Victoza.

Although both drugs were backed for approval by an FDA advisory panel in July, Sanofi’s decision date was earlier than Novo’s, giving the French drugmaker an advantage. That edge essentially disappeared with the FDA pushback.

According to Leerink Partners, what’s at stake is about $5 billion in peak sales for Novo’s Xultophy and $1.5 billion to $2 billion for Sanofi’s LixiLan.

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

- check out Sanofi’s release (PDF)

Read more:
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Sanofi cuts the FDA line with a diabetes combo, hoping to lap Novo
Sanofi's combo LixiLan ready to go to FDA in ongoing scramble for diabetes dominance