Regulatory submission in Japan for Forxiga in type-1 diabetes
Regulatory submission in Japan for Forxiga in type-1 diabetes Japan submission follows European regulatory submission acceptance in March 2018 AstraZeneca has submitted a supplemental new drug application (sNDA) to Japan's Pharmaceuticals and Medical Devices Agency (PMDA) for the use of Forxiga (dapagliflozin), a selective sodium-glucose co-transporter 2 (SGLT2) inhibitor, as an oral adjunct treatment to insulin in adults with type-1 diabetes (T1D). The Japan sNDA is based on Phase III data from the DEPICT (Dapagliflozin Evaluation in Patients with Inadequately Controlled Type 1