The FDA declined to approve Zynquista a drug developed by Sanofi SA and Lexicon Pharmaceuticals intended for use with insulin in patients with Type 1 Diabetes. The generic name of the drug is sotagliflozin.
The decision comes about two months after an FDA advisory panel divided over whether the once-daily oral drug 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 by removing excess blood sugar through the urine and reduce the risk of weight gain.
The FDA panel members in January had raised concerns about the risk of diabetic ketoacidosis (DKA), leaving them unable to decide whether the treatment’s benefits outweighed the risks.
The companies had proposed a Risk Evaluation and Mitigation Strategy (REMS) for the drug and said regular testing of ketone levels should be required but this apparently did not provide the FDA sufficient assurances of patient safety.
See this article for details on SGLT2 Inhibitors.
The decision is controversial.
“JDRF is disappointed that the U.S. Food and Drug Administration (FDA) has not approved sotagliflozin (Zynquista
On March 25, only days after the FDA rejected Zynquista for T1D use, the European Medicines Agency approved another SGLT2 inhibitor, Forxiga, for adults with T1D. Forxiga is AstraZeneca brand name for dapagliflozin which is marketed in the United States as Farxiga. See release.
