FDA split over whether to approve oral type 1 diabetes drug

The US Food and Drug Administration (FDA) is split over whether the oral diabetes drug Zynquista (sotagliflozin) should be approved.
The US regulators have cast concern over the increased risk of diabetic ketoacidosis (DKA) associated with the drug, an oral type 1 diabetes drug, which went under FDA review in 2018.
Zynquista, developed by Sanofi in partnership with Lexicon Pharmaceuticals, is designed to improve blood glucose control without increasing hypoglycemia, but fears have emerged over the potential of it bringing a higher risk of DKA.
The drug is a tablet which inhibits SGLT-1 and SGLT-2, proteins that influence how the intestines and kidneys absorb and glucose, resulting in improved control.
The drug has been submitted for approval to the European Medicines Agency (EMA) and the FDA. The EMA is expected to issue its approval decision over the coming months.
The FDA’s Endocrinologic and Metabolic Drugs Advisory Committee, which advises decision makers at the organisation, is split on whether to recommend the drug.
Last week, eight committee members voted for and eight against when posed the question of whether the drug’s benefits outweighed the risks overall.
Committee members flagged concerns that people using it outside of clinical trial conditions would have an even greater risk of developing DKA, but some members also said their fears could be alleviated if a risk evaluation and mitigation strategy was developed and tested.
It is predicted that the FDA will make the final decision during a meeting by 22 March.
Dr Rachele Berria, Sanofi’s Global Vice President and Head of Diabetes Medical Affairs, said: “We believe in the overall benefit-risk profile of sotagliflozin for adults with type 1 diabetes who lack adequate glycemic control using insulin alone. 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.”