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LONDON (Alliance News) - FTSE 100-listed drug maker AstraZeneca PLC said Wednesday its blockbuster Forxiga drug had been approved by Japan for the treatment of diabetes alongside insulin.
The Japanese Ministry of Health, Labour & Welfare has approved Forxiga, the brand name of dapagliflozin, for the oral adjunct treatment to insulin for adults with type-1 diabetes.
The approval follows data from its phase three DEPICT clinical trial as well as a separate trial with Japanese patients. These trials showed the combined treatment of Forxiga and insulin "demonstrated significant and clinically-meaningful reductions" in average blood glucose levels.
The trial results for type-1 diabetes were said to have been "consistent" with those of the "well-established" profile for the drug in type-2 diabetes.
"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," AstraZeneca Cardiovascular, Renal & Metabolism Head Elisabeth Bjork said.
"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", Bjork added.
Forxiga had already been approved for adjunct treatment for type-1 diabetes by the European Commission last Wednesday. It is currently under review for the same treatment in the US, with a decision expected in the second half of 2019.
Shares in AstraZeneca were 1.0% lower at 6,348.00 pence early on Wednesday.
