FDA Accepts NDA for Investigational Type 1 Diabetes Oral Drug


Sanofi announced that the FDA has accepted the New Drug Application (NDA) for Zynquista (sotagliflozin).

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.

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