The U.S. Food and Drug Administration declined to approve a drug developed by Sa...
- The U.S. Food and Drug Administration declined to approve a drug developed by Sanofi SA and Lexicon Pharmaceuticals Inc intended for use with insulin in patients with type 1 diabetes, the companies said on Friday.
The decision comes about two months after an FDA advisory panel failed to reach a consensus over whether the once-daily oral drug, sotagliflozin, should be approved as an add-on to insulin therapy. Sotagliflozin, works by inhibiting the proteins SGLT1 and SGLT2 to help regulate blood glucose levels and reduce the risk of weight gain.
The FDA panel members in January had raised concerns of the risk of diabetic ketoacidosis , leaving them divided over whether the treatment’s benefits outweighed the risks.
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