EU Granted Marketing Authorization for Sanofi and Lexicon’s Zynquista

| By | EU Approved, Lexicon, Sanofi

The European Commission has granted marketing authorization for Zynquista™ (sotagliflozin), developed by Sanofi and Lexicon. Zynquista is now approved in the European Union, at once-daily doses of 200 mg and 400 mg, for use as an adjunct to insulin therapy to improve blood sugar (glycemic) control in adults with type 1 diabetes (T1D) mellitus and a body mass index ≥ 27 kg/m2, who could not achieve adequate glycemic control despite optimal insulin therapy.

“Millions of people across Europe who live with type 1 diabetes struggle to control their blood sugar, even with optimal insulin therapy,”

commented Thomas Danne, Professor of Pediatrics, Children’s Hospital ‘Auf der Bult,’ Hannover, Germany.

“For the many people living with type 1 diabetes who are overweight or obese, Zynquista will offer a new treatment option physicians can now consider in combination with insulin therapy for appropriate patients.”

Zynquista is an oral dual inhibitor of two proteins responsible for glucose regulation known as sodium-dependent glucose co-transporter types 1 and 2 (SGLT1 and SGLT2). SGLT1 is responsible for glucose absorption in the gastrointestinal tract, and SGLT2 is responsible for glucose reabsorption by the kidney.

“Zynquista’s dual mechanism of action provides important treatment benefits for adults with type 1 diabetes, including reducing blood sugar reabsorption in the kidneys through SGLT2 inhibition and delaying dietary sugar absorption through local SGLT1 inhibition in the intestinal tract,”

added John Reed, M.D., Ph.D., Global Head of Research & Development, Sanofi.

The marketing authorization 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, involving approximately 3,000 adults with inadequately controlled T1D.4-7

“We are proud to have developed Zynquista in combination with insulin through the largest Phase 3 clinical trial program to date in adults with type 1 diabetes, and now to have it approved in the European Union,”

said Pablo Lapuerta, M.D., Executive Vice President and Chief Medical Officer, Lexicon.

“We thank the European Commission for recognizing the clinical benefits of Zynquista for adults with type 1 diabetes and the families and physicians who participated in the clinical trials.”

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 and significant reductions from baseline at 24 weeks in average blood sugar (HbA1c), body weight, systolic blood pressure, a significant improvement of time in target blood sugar range and improved patient-reported outcomes, versus insulin alone, at both 200-mg and 400-mg doses. This was achieved without the usual increase in severe hypoglycemia that comes with intensification of insulin and with less events of severe hypoglycemia in the 400-mg dose at 52 weeks.

Consistent with selective SGLT2 inhibitors, clinical trials with sotagliflozin showed an increased risk of genital mycotic infections and diabetic ketoacidosis (DKA), which is acknowledged to affect people with T1D more frequently than those with type 2 diabetes (T2D). Several leaders in the diabetes scientific community consider the risk of DKA associated with SGLT inhibitors manageable with appropriate patient selection, education and ketone monitoring in place. The risk of DKA will be addressed by careful selection of patients for treatment with sotagliflozin and through a risk-management plan and a mitigation strategy, including patient, healthcare professional and care giver educational activities, that will support its safe use.

Zynquista is also currently being evaluated in a program of 11 clinical trials in adults with T2D, including two trials in people living with T2D and renal impairment, and two large cardiovascular outcomes trials.

GMP news
Pharmaceutical industry News and events. Technology transfer and contract manufacturing of medicines.