Update on US regulatory decision for Farxiga
15 July 2019 07:00 BST Update on US regulatory decision for Farxiga in type-1 diabetes AstraZeneca today 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,