FDA Advisory Committee Votes on Zynquista™ (sotagliflozin) as Treatment for Adults With Type 1 Diabetes
Lexicon Pharmaceuticals, Inc. (LXRX)
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Source: GlobeNewswire
PARIS and THE WOODLANDS, Texas, Jan. 17, 2019 (GLOBE NEWSWIRE) -- The Endocrinologic and Metabolic Drugs Advisory Committee of the U.S. Food and Drug Administration (FDA) today voted eight to eight on the question of whether the overall benefits of Zynquista™* (sotagliflozin) outweighed the risks to support approval. Sotagliflozin is an investigational oral dual SGLT1 and SGLT2 inhibitor under regulatory review as an adjunct to insulin for the treatment of adults with type 1 diabetes (T1D). While the FDA is not required to follow the committee’s vote, the agency considers the committee’s recommendations when making its decision, which is anticipated by March 22, 2019. Sotagliflozin, developed by Sanofi and Lexicon, has the potential to be the first oral antidiabetic drug approved in the United States together with insulin therapy to improve glycemic (blood sugar) control in adults with T1D. “We believe in the overall benefit-risk profile of sotagliflozin for adults with type 1 dia
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News
- All You Need to Know About Lexicon (LXRX) Rating Upgrade to Buy [Yahoo! Finance]Yahoo! Finance
- Lexicon Pharmaceuticals, Inc. (NASDAQ: LXRX) was upgraded by analysts at StockNews.com to a "sell" rating.MarketBeat
- Lexicon Pharmaceuticals, Inc. (NASDAQ: LXRX) had its "hold" rating re-affirmed by analysts at Needham & Company LLC.MarketBeat
- Lexicon Pharmaceuticals to Participate in the 23rd Annual Needham Virtual Healthcare ConferenceGlobeNewswire
- Clinical Data on the Impact of Sotagliflozin on Stroke and Heart Attack Risk Among Four Lexicon-Sponsored Presentations at the American College of Cardiology 73rd Annual Scientific Session & Expo [Yahoo! Finance]Yahoo! Finance
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