AstraZeneca PLC is seeking Japanese approval for its drug Forxiga as treatment for type 1 diabetes.
The Cambridge, U.K.-based drugmaker submitted a supplemental new drug application to Japan's Pharmaceuticals and Medical Devices Agency for Forxiga, or dapagliflozin, as an additional oral therapy to insulin for patients with type 1 diabetes.
The submission is based on phase 3 data from the company's Depict clinical program, as well as a dedicated trial in Japanese patients.
AstraZeneca is also seeking EU approval for Forxiga for the same indication.
Forxiga, or dapagliflozin, was recently shown to improve blood sugar levels and body weight in certain patients with type 2 diabetes and with stage 3A chronic kidney disease in a phase 3 study.
The drug is also known as Farxiga in the U.S. and was approved by Japanese Ministry of Health, Labor and Welfare in 2014 to treat type 2 diabetes.