Sanofi/Lexicon Diabetes Drug Gets 8-8 Vote From FDA Panel -- Update
January 17 2019 - 07:56PM
Dow Jones News
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 josh.beckerman@wsj.com
(END) Dow Jones Newswires
January 17, 2019 19:41 ET (00:41 GMT)
Copyright (c) 2019 Dow Jones & Company, Inc.
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