FDA Accepts Zynquista NDA for Type 1 Diabetes

Sanofi announced that the US Food and Drug Administration (FDA) accepted the New Drug Application for Zynquista (sotagliflozin). The investigational oral drug is intended to be taken alongside insulin therapy to help manage blood sugar levels in adults with type 1 diabetes.

"If approved, Zynquista would be the first oral antidiabetic drug approved in the US for use by adults with type 1 diabetes, in combination with insulin," said Jorge Insuasty, Senior-Vice President, Global Head of Development, Sanofi, in a statement. "We look forward to working with the FDA through the review process with a view towards bringing this investigational medicine to adults with type 1 diabetes in the US."

Sotagliflozin is an oral dual inhibitor of SGLT-1 and SGLT-2, proteins that affect the absorption and elimination of sugar in the intestines and kidneys. The result is improved glucose control for patients with type 1 diabetes.

Results from the inTandem clinical trials support Sanofi’s New Drug Application for Zynquista. In inTandem1, sotagliflozin met the primary endpoint of change in hemoglobin A1C levels from baseline to 24 weeks. Changes in A1C levels were 0.43% for the 200-mg dose, and 0.49% for the 400-mg dose, and 0.08% for placebo. inTandem2 produced similar results.

The third inTandem trial included 1405 patients with type 1 diabetes and baseline A1C levels between 7% and 11%. The randomized, double-blind study showed that 400mg sotagliflozin reduced A1C 0.79% from baseline compared with 0.33% for placebo, after 24 weeks of treatment (p<0.001).

"After decades of little change and innovation, the treatment of type 1 diabetes has begun to shift significantly and, if approved, our dual SGLT-1 and SGLT-2 inhibitor, Zynquista, would be the first approved oral therapy used in combination with insulin to improve glycemic control and patient outcomes for adults in the United States who are living with type 1 diabetes," said Pablo Lapuerta, MD, executive vice president and chief medical officer, Lexicon.

The company expects FDA action in the first quarter of 2019. The Prescription Drug User Fee Act (PDUFA) is anticipated to be March 22, 2019. The company has also submitted a regulatory application to the European Medicines Agency.

"The acceptance of the NDA filing moves us closer to providing a meaningful option for people with type 1 diabetes and we look forward to continuing to work closely with the FDA during the review process," said Lapuerta.