It is also the first AstraZeneca medicine ever approved for type-1 diabetes.
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 Björk, senior vice president, head of late cardiovascular, renal and metabolism, R&D BioPharmaceuticals, AstraZeneca 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.”
The approval is based on data from the Phase III DEPICT clinical programme and a dedicated trial in Japanese patients.
Forxiga was approved by the European Commission on 20 March as the first oral adjunct treatment in Europe for adults with T1D. The medicine is under regulatory review in the US for the same indication, with a decision expected in the second half of 2019.
Forxiga is the first AstraZeneca medicine ever approved for type-1 diabetes. [APBN]