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Pharmaceuticals / Submissions and Approvals

Japanese Regulators Greenlight AstraZeneca’s Diabetes Treatment

April 9, 2019
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AstraZeneca’s diabetes-1 treatment, Forxiga (dapagliflozin), has won approval from Japan’s Pharmaceuticals and Medical Devices Agency.

Forxiga is used as an adjunct to insulin for diabetic adults. The approval was based on results from Phase III trials in which Forxiga helped reduce baseline blood-sugar levels of patients whose diabetes resisted control through traditional means.

The drug won approval from European regulators in March as an adjunct to insulin. AstraZeneca is optimistic that the FDA will approve the drug later this year.

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