Posted by Michael Wonder on 15 Jul 2019
Update on US regulatory decision for Farxiga in type 1 diabetes
15 July 2019 - AstraZeneca today announced that the US 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 mellitus, 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 (5 mg) and Japan (5 mg, potential up-titration to 10 mg) under the name Forxiga, as an adjunct to insulin in adults with type 1 diabetes mellitus.
