The Japanese Ministry of Health, Labour and Welfare (MHLW) has approved?Forxiga?(dapagliflozin) as an oral adjunct treatment to insulin for adults with type-1 diabetes (T1D). Elisabeth Bj?rk, Senior Vice President, Head of late Cardiovascular, Renal and Metabolism, R&D BioPharmaceuticals, said: ?This approval of?Forxiga?in Japan means that people with type-1 diabetes whose glucose levels are not adequately controlled with insulin alone now have a new oral treatment option available to them.?Forxiga?will help address a significant unmet need in this patient population, and this approval in type-1 diabetes builds on the well-established clinical profile of?Forxiga.? The approval is based on data from the Phase III DEPICT clinical programme and a dedicated trial in Japanese patients (D1695C00001). Results showed that?Forxiga,?when given as an oral treatment in addition to adjustable insulin in patients with inadequately-controlled T1D, demonstrated significant and clinically-meaningful reductions from baseline in average blood glucose levels HbA1c (primary endpoint), weight and total daily insulin dose (secondary endpoints) at 24 weeks^1,2,3, at both 5mg and 10mg doses. The safety profile of?Forxiga?in these T1D trials was consistent with its well-established profile in type-2 diabetes (T2D), with the exception of a higher number of diabetic ketoacidosis (DKA) events in?Forxiga-treated patients versus placebo. DKA is a known complication for adults with T1D that affects those with T1D more frequently than with T2D.?Forxiga?is already indicated as a monotherapy and as part of combination therapy in adults with T2D to improve glycaemic control as an adjunct to diet and exercise. Forxiga?was approved by the European Commission on 20 March as an adjunct treatment to insulin in adults with T1D, and the medicine is under regulatory review in the US for the same indication, with a decision expected in the second half of 2019. About type-1 diabetes T1D is a chronic disease in which the pancreas produces little or no insulin. Approximately five percent of people living with diabetes have type-1. The condition is caused by an autoimmune reaction that destroys the beta cells in the pancreas which make insulin.4 Different factors, including genetics and some viruses, may contribute to type-1 diabetes.⁵ About the DEPICT clinical programme The DEPICT (Dapagliflozin?Evaluation in?Patients with?Inadequately?Controlled?Type 1 Diabetes) clinical trial programme consists of two trials: DEPICT-1 and DEPICT-2 which are 24-week, randomised, double-blinded, parallel-controlled trials designed to assess the effects of?Forxiga?5mg or 10mg on glycaemic control in patients with T1D inadequately controlled by insulin. All patients were evaluated at week 24 and after a 28-week extension (52 weeks in total). About?Forxiga Forxiga?(dapagliflozin)?is a first-in-class, oral once-daily selective inhibitor of human sodium-glucose co-transporter 2 (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.?Forxiga?has a robust clinical trial programme of more than 35 completed and ongoing Phase IIb/III trials in over 35,000 patients, as well as more than 1.8 million patient-years? experience. Outside T2D,?Forxiga?is also approved in T1D in the EU. About AstraZeneca in Cardiovascular, Renal & Metabolism (CVRM) Cardiovascular, renal and metabolism together form one of AstraZeneca?s main therapy areas and a key growth driver for the Company. By following the science to understand more clearly the underlying links between the heart, kidneys and pancreas, AstraZeneca is investing in a portfolio of medicines to protect organs and improve outcomes by slowing disease progression, reducing risks and tackling co-morbidities. Our ambition is to modify or halt the natural course of CVRM diseases and potentially regenerate organs and restore function, by continuing to deliver transformative science that improves treatment practices and cardiovascular health for millions of patients worldwide. About AstraZeneca AstraZeneca is a global, science-led biopharmaceutical company that focuses on the discovery, development and commercialisation of prescription medicines, primarily for the treatment of diseases in three therapy areas - Oncology, Cardiovascular, Renal & Metabolism and Respiratory. AstraZeneca operates in over 100 countries and its innovative medicines are used by millions of patients worldwide.