FDA Issues CRL for Sotagliflozin


The FDA’s decision regarding sotagliflozin (Zynquista), an investigational treatment for type 1 diabetes, followed a split Advisory Committee vote in January.


Today the US Food and Drug Administration (FDA) issued a Complete Response Letter (CRL) in response to the New Drug Application (NDA) for sotagliflozin (Zynquista). The investigational drug was seeking an indication for the treatment of adults with type 1 diabetes (T1D) in combination with insulin.

Earlier this year, in January, an FDA Advisory Committee split evenly on the vote: 8-8. The committee expressed concern over the association of sodium-glucose cotransporter-2 (SGLT2) inhibitors to increased risk of diabetic ketoacidosis (DKA).

At the time of the split vote, Rachele Berria, MD, PhD, Global Vice President and Head of Diabetes Medical Affairs, Sanofi, spoke in response.

“We believe in the overall benefit-risk profile of sotagliflozin for adults with type 1 diabetes who lack adequate glycemic control using insulin alone,” said Berria. “We will continue to work with the FDA through its review process to hopefully bring to patients a new treatment that can help people living with type 1 diabetes control their blood sugar and address some of the challenges of insulin-only therapy.”

Sotagliflozin is a dual SGLT1 and SGLT2 inhibitor that was studied in clinical trials including inTandem 1, 2, and 3.

Sanofi and Lexicon Pharmaceuticals indicated that following this CRL, they will work with the FDA to determine next steps.

Sotagliflozin is also under regulatory review by the European Medicines Agency (EMA). A decision from the EMA is expected in the first half of 2019.

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