AstraZeneca Plc (LON:AZN), a global, science-led biopharmaceutical company, announced on Monday the issue by the US Food and Drug Administration (FDA) of 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.

According to AstraZeneca, it will work closely with the FDA to discuss the next steps.

The company said 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.

Farxiga (dapagliflozin) is a first-in-class, oral, once-daily selective inhibitor of SGLT2 indicated as both monotherapy and as part of combination therapy to improve glycaemic control, with the additional benefits of weight loss and blood-pressure reduction, as an adjunct to diet and exercise in adults with T2D.

Reportedly, Farxiga has a robust clinical trial programme of over 35 completed and ongoing phase IIb/III trials with over 35,000 patients, as well as more than 1.8 million patient-years' experience.

AstraZeneca is focussed on the discovery, development and commercialisation of prescription medicines, primarily for the treatment of diseases in the three therapy areas of Oncology, Cardiovascular, Renal & Metabolism and Respiratory.