New application in Japan



AstraZeneca said Monday it had submitted a new drug application to Japan’s Pharmaceuticals and Medical Devices Agency for its oral adjunct treatment to insulin in adults with type-1 diabetes. The application was based on Phase III data from the DEPICT - Dapagliflozin Evaluation in Patients with Inadequately Controlled Type 1 Diabetes - clinical programme for Forxiga in type-1 diabetes and a dedicated trial in Japanese patients. The application for Forxiga, which provided the added benefits of blood pressure reductions and weight loss in adult patients with type-2 diabetes, comes after regulatory submission for the drug was accepted in Europe earlier this year, the firm said Story provided by