The move comes a month after FDA issued a Complete Response Letter on the drug, despite pleas from patient advocates to approve a new treatment option in type 1 diabetes.
The European Commission yesterday approved sotagliflozin, a dual inhibitor sold as Zynquista, to be marketed in the European Union for certain overweight adults with type 1 diabetes (T1D). Sanofi is developing the drug with Lexicon Pharmaceuticals.
The move comes a month after the FDA issued a Complete Response Letter for sotagliflozin, which blocks both the sodium glucose cotransporter (SGLT) 1 and 2 proteins involved in the reabsorption of glucose otherwise expelled in the urine; SGLT1 reabsorbs glucose in the gastrointestinal tract, while SGLT2 reabsorbs it in the kidney. An FDA advisory panel split on recommending the drug for T1D based on a small but increased risk of diabetic ketoacidosis.
European Commission officials approved sotagliflozin, an oral therapy, for patients with a body mass index of 27 kg/m2 or more. It is available in once-daily doses of 200 mg or 400 mg.
“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,” said John Reed, MD, PhD, global head of research and development, Sanofi, in a statement.
Advocates in the T1D community have pressed FDA to approve sotagliflozin, after studies showed that it could reduce the glycemic variability they live with daily while treating their disease with insulin. Diabetes experts are increasingly emphasizing time in range as a more important measure than glycated hemoglobin, both as a measure of health in patients and a better predictor of long-term complications.
“Millions of people across Europe who live with type 1 diabetes struggle to control their blood sugar, even with optimal insulin therapy,” Thomas Danne, professor of pediatrics, Children’s Hospital ‘Auf der Bult,’ Hannover, Germany, said in a statement from Sanofi. “For the many people living with type 1 diabetes who are overweight or obese, Zynquista will offer a new treatment option that physicians can now consider in combination with insulin therapy for appropriate patients.”