PARIS and THE WOODLANDS, TX – March 1, 2019 – The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion on the Marketing Authorization of ZynquistaTM* (sotagliflozin), developed by Sanofi and Lexicon. The CHMP recommended approval of sotagliflozin in the European Union (EU) in both a 200-mg and 400-mg dose for use as an adjunct to insulin therapy to improve blood sugar (glycemic) control in adults with type 1 diabetes (T1D) mellitus with a body mass index >= 27 kg/m2, who have failed to achieve adequate glycemic control despite optimal insulin therapy.
Sotagliflozin is an investigational oral dual inhibitor of two proteins responsible for glucose regulation known as sodium-dependent glucose co-transporter types 1 and 2 (SGLT1 and SGLT2).1 SGLT1 is responsible for glucose absorption in the gastrointestinal tract,2 and SGLT2 is responsible for glucose reabsorption by the kidney.3 The CHMP opinion is based on evidence including data from the inTandem clinical trial program, which included three Phase 3 clinical trials assessing the safety and efficacy of sotagliflozin in approximately 3,000 adults with inadequately controlled T1D. These three trials demonstrated that treatment with sotagliflozin, when given to adults with inadequately controlled T1D as an oral adjunct to insulin, resulted in consistent, significant reductions from baseline at 24 weeks in average blood sugar (HbA1c), body weight, systolic blood pressure and a significant improvement of time in target blood sugar range, versus insulin alone, at both 200-mg and 400-mg doses.4-7
The European Commission is expected to make a final decision on the Marketing Authorization Application for sotagliflozin in the EU in the coming months. Sotagliflozin is also currently being reviewed by the U.S. Food and Drug Administration (FDA) and has the potential to be the first oral antidiabetic drug approved in the U.S. for use together with insulin therapy to improve glycemic control in adults living with T1D. The target FDA action date under the Prescription Drug User Fee Act (PDUFA) is anticipated to be March 22, 2019.8 * The EMA and FDA have conditionally accepted Zynquista(TM) as the trade name for sotagliflozin.