Home » European Regulators Okay Diabetes Treatment, One Month After U.S. Slaps It Back
European Regulators Okay Diabetes Treatment, One Month After U.S. Slaps It Back
May 3, 2019
European regulators have approved diabetes treatment Zynquista (sotagliflozin) barely a month after U.S. regulators put the drug into limbo.
The European Commission approved Lexicon’s and Sanofi’s protein inhibitor as an adjunct to insulin for type 1 diabetics. The approval was based on data from three clinical trials involving nearly 3,000 adults.
The approval also comes about five weeks after the FDA sent Lexicon and Sanofi a complete response letter, and more than four months after an FDA advisory committee deadlocked on the drug’s safety profile. Some experts are worried that Zynquista could cause a dangerous spike in blood acidity.
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