Sanofi/Lexicon Diabetes Drug Gets 8-8 Vote From FDA Panel -- Update

   By Josh Beckerman 
 

A diabetes drug being developed by Sanofi (SNY) and Lexicon Pharmaceuticals Inc. (LXRX) received a tie vote from a U.S. Food and Drug Administration advisory panel.

Lexicon shares fell 31.8% to $5.25 after hours. Before the 8-8 vote on Zynquista, the shares had been halted all day.

The FDA isn't required to follow the advice of such advisory panels, but it generally does so. An FDA decision is expected by March 22.

The companies said they will continue to work with the FDA through its review process.

In clinical trials, when combined with insulin therapy, Zynquista "significantly improved glycemic control without increasing hypoglycemia."

An increase in diabetic ketoacidosis was seen with sotagliflozin compared to insulin alone, the companies said. They said diabetic ketoacidosis "is an inherent risk of type 1 diabetes" and believe this "can potentially be addressed with proper education and monitoring."

A Lexicon conference call was scheduled to start at 7:00 p.m. EST.

Lexicon and Sanofi entered a collaboration and license agreement for the drug in November 2015.

Lexicon's first commercial product was Xermelo, which treats carcinoid syndrome diarrhea.

Write to Josh Beckerman at [e-mail]

(END) Dow Jones Newswires

January 17, 2019 19:41 ET (00:41 GMT)

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