FDA Rejects SGLT Drug Zynquista for T1D Use

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™) at this time for adults with type 1 diabetes (T1D). It is critical that we add new therapy options for people with T1D in order to address the unmet needs of our community. We expect that the FDA and drug manufacturers will continue working together to safely bring this option to people with T1D in the future and are thankful for the FDA’s consideration and review of this drug. In the meantime, we will continue to research new treatments to better manage T1D and are also looking forward to the availability of other options in the pipeline.” said JDRF Chief Mission Officer Aaron Kowalski, Ph.D.

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.