AstraZeneca gets US FDA complete response letter on sBLA for Farxiga in type-1 diabetes

AstraZeneca announced that the US Food and Drug Administration (FDA) has issued a complete response letter regarding the supplemental New Drug Application for Farxiga (dapagliflozin) as an adjunct treatment to insulin to improve glycaemic control in adult patients with type-1 diabetes (T1D), when insulin alone does not provide adequate glycaemic control. AstraZeneca will work closely with the FDA to discuss the next steps. Farxiga was recently approved in Europe (5mg) and Japan (5mg, potential up-titration to 10mg) under the name Forxiga, as an adjunct to insulin in adults with T1D.

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