LONDON (dpa-AFX) - AstraZeneca plc (AZN.L, AZN) has received a complete response letter from the US FDA with respect to the supplemental New Drug Application for Farxiga (dapagliflozin) filed by the company as an adjunct treatment to insulin to improve glycaemic control in adult patients with type-1 diabetes. AstraZeneca said it will work closely with the FDA regarding the next steps.
Farxiga (dapagliflozin) is an oral, once-daily selective inhibitor of SGLT2 indicated as both monotherapy and as part of combination therapy to improve glycaemic control as an adjunct to diet and exercise in adults with type-1 diabetes.
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