FDAnews Drug Daily Bulletin
Pharmaceuticals / Regulatory Affairs

European Regulators Okay Diabetes Treatment, One Month After U.S. Slaps It Back

May 6, 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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