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AstraZeneca: Japan Approves Forxiga For Type-1 Diabetes - Quick Facts

AstraZeneca Plc (AZN.L,AZN) announced Wednesday that Forxiga has received approval in Japan for Type-1 Diabetes or T1D.

The Japanese Ministry of Health, Labour and Welfare or MHLW has approved Forxiga (dapagliflozin) as an oral adjunct treatment to insulin for adults with T1D.

The approval is based on data from the Phase III DEPICT clinical programme and a dedicated trial in Japanese patients.

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).

Forxiga recently was approved by the European Commission as an adjunct treatment to insulin in 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.

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