BRIEF—FDA issues CRL on Farxiga in type 1 diabetes

AstraZeneca today announced that the US Food and Drug Administration has issued a complete response letter (CRL) regarding the supplemental New Drug Application for Farxiga dapagliflozin) as an adjunct treatment to insulin to improve glycemic control in adult patients with type-1 diabetes (T1D), when insulin alone does not provide adequate glycemic control.

AstraZeneca said it will work closely with the FDA to discuss the next steps, but gave no indication as to what the US regulator was seeking in additional information/action in order to approve the drug in this indication.

Farxigawas 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.

Farxiga is already approved in the USA for use in type-2 diabetes.