FDA Turns Down Sotagliflozin for Type 1 Diabetes

Miriam E. Tucker

March 22, 2019

The US Food and Drug Administration (FDA) has rejected sotagliflozin (Sanofi/Lexicon) as an adjunct to insulin for the treatment of type 1 diabetes.

The decision follows a split vote in January 2019 by the FDA's Endocrinologic and Metabolic Drugs Advisory Committee, during which panel members expressed concerns about an increased risk for diabetic ketoacidosis (DKA) with the drug in type 1 diabetes. Even panel members who voted to recommend approval said they would endorse strict rules for a Risk Evaluation and Mitigation Strategies (REMS) program for the drug's use in the event of it being approved.

The FDA decision contrasts with the positive opinion of the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) earlier this month. This will allow marketing of sotagliflozin (to be known there as Zynquista) as an adjunct to insulin to improve blood glucose in adults with type 1 diabetes with a body mass index ≥ 27 kg/m 2 who haven't achieved adequate glycemic control with optimal insulin therapy and are under the care of specialist physicians.

Sotagliflozin, a dual inhibitor of sodium-glucose cotransporter types 1 and 2 (SGLT1 and SGLT2), has not yet been approved in any country for either type of diabetes, although the CHMP positive opinion means that European Union approval for the indication outlined above — in certain type 1 diabetes patients — is a formality within a couple of months of that decision.

Simeon I. Taylor, MD, PhD, professor of medicine at the University of Maryland School of Medicine in Baltimore, who has previously expressed concerns about the use of the SGLT2 inhibitor class in type 1 diabetes, applauded the FDA's decision.

"It is reassuring that FDA took an evidence-based approach to protect type 1 diabetic patients," Taylor told Medscape Medical News, pointing out that, while the improvement in glycemia was modest, use of sotagliflozin in patients with type 1 diabetes would be expected to cause an additional 5000 cases of DKA and 20 deaths each year, based on data from carefully conducted clinical trials and an assumption that about 10% of patients would be using it.

"It is a near certainty that real world outcomes will be worse," he noted.

But Aaron Kowalski, PhD, Chief Mission Officer of the JDRF, took a different view: "JDRF is disappointed that the U.S. 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 FDA's consideration and review of this drug," Kowalski added.

"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."

Taylor was previously employed at Bristol-Myers Squibb, and is currently a consultant for Ionis Pharmaceuticals, has research support provided to the University of Maryland School of Medicine by Regeneron, and owns stock in Celgene, Amgen, and Abbott Laboratories.

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