The American drug agency (FDA) has accepted the regulatory presentation of the Sanofi Pharmaceutical Company for Zynquista (Sotagliflozina), which will review the possible use of this drug in combination with insulin treatment to improve blood sugar control inAdults with type I diabetes.
"If approved, Zynquista would be the first oral antidiabetic drug approved in the United States for adults with type I diabetes, in combination with insulin," explains Senior Vice President and Global Head of Development of Sanofi, Jorge Insuasty."We hope to work with the FDA through the revision process with a view to carrying this drug in adults with type I diabetes in the United States," he adds.
Developed in association with Lexicon Pharmaceuticals, Zynquista is a double oral inhibitor in SGLT-1 and SGLT-2 research, proteins that influence how intestines and kidneys absorb and eliminate sugar (glucose), improving glucose control andWith additional clinical benefits.
Few changes so far
“After decades of few changes and innovations, the treatment of type I diabetes has begun to change significantly and, if approved, our double SGLT1 and SGLT2, zynquista inhibitor would be the first oral therapy approved in combination with insulin to improve theglycemic control and the results of adult patients in the United States living with type I diabetes, ”describes the executive vice president and medical director of Lexicon, Dr. Pablo Lapuerta.
"The acceptance of the presentation of NDA brings us closer to providing a significant option for people with type I diabetes and we hope to continue working closely with the FDA during the review process," adds Pablo Lapuerta.
The new application of the FDA for Sotagliflozine is based on data from the INTANDEM clinical trial program that includes three clinical trials in phase III that evaluate the safety and efficacy of zynquista in approximately 3,000 adults with diabetes type I inadequately controlled.Security and efficiency data have not yet been evaluated by any regulatory authority.
