Pharmaceutical

Lexicon Pharmaceuticals (Nasdaq:LXRX), today announced that the U.S. Food and Drug Administration (FDA) Endocrinologic and Metabolic Drugs Advisory Committee (EMDAC) plans to review Lexicon collaborator Sanofi’s New Drug Application (NDA) for sotagliflozin, an investigational oral treatment for adults with type 1 diabetes, on January 17, 2019. As quoted in the press release: The FDA accepted the …

Lexicon Pharmaceuticals (Nasdaq:LXRX), today announced that the U.S. Food and Drug Administration (FDA) Endocrinologic and Metabolic Drugs Advisory Committee (EMDAC) plans to review Lexicon collaborator Sanofi’s New Drug Application (NDA) for sotagliflozin, an investigational oral treatment for adults with type 1 diabetes, on January 17, 2019.

As quoted in the press release:

The FDA accepted the NDA for sotagliflozin on May 22, 2018. The NDA included data from the inTandem clinical trial program, which includes three Phase 3 clinical trials assessing the safety and efficacy of sotagliflozin in approximately 3,000 adults with inadequately controlled type 1 diabetes.

The target date for an FDA action regarding sotagliflozin under the Prescription Drug User Fee Act (PDUFA) is anticipated to be March 22, 2019.

Click here to read the full press release.

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