Zynquista™ (sotagliflozin) New Drug Application Accepted by the FDA

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Lexicon Pharmaceuticals Inc., in partnership with Sanofi, announced recently that the U.S. Food and Drug Administration (FDA) has accepted Sanofi’s New Drug Application (NDA), or regulatory filing, for Zynquista™ (sotagliflozin). The investigational oral treatment would be used in addition to insulin therapy to improve blood glucose control in adults with type 1 diabetes (T1D). Sotagliflozin is a type of drug that helps users avoid high blood-sugar levels by increasing excretion of glucose via urine.

FDA expected target action date on the application is March 22, 2019. Sanofi also submitted a regulatory application to the European Medicines Agency for sotagliflozin earlier this year. This is a positive step in the treatment of T1D. It is easy for people with T1D to take sotagliflozin, as they would take it once a day orally.

JDRF jointly funded a phase II clinical trial (NCT02383940) to test sotagliflozin in young adults, aged 18 to 30 years, with elevated HbA1c (above 9 percent). The study showed significant benefits with meaningful outcomes for T1D without any increase in hypoglycemia or risk of ketoacidosis at 12 weeks. Following a phase III study, the findings of the trials showed that sotagliflozin not only reduced A1c in adults with T1D but also improved other key health measures, such as time in range, body weight and blood pressure, without increasing hypoglycemia.

The FDA’s acceptance of Lexicon Pharmaceuticals’ NDA is one step closer to providing an additional option for people with T1D to help improve their blood sugar control. If the FDA approves sotagliflozin, it will be the first new drug class approved for T1D in nearly 15 years, and the first oral drug approved in the United States for T1D as an adjunct to insulin.

Tighter glucose control reduces the risks of complications and we’re committed to funding research that explores new ways to make it easier to manage T1D. To learn more about our work in glucose control, click here, and read our previous coverage on the drug here.