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Takeda wins approval for additional indication of diabetes drug

Takeda Pharmaceutical Company has received approval for an additional indication of concomitant therapy with biguanides for Actos, medicine for type 2 diabetes, from the Ministry of Health, Labour and Welfare in Japan.

According to the company, Actos directly targets insulin resistance, a condition characterized in patients with type 2 diabetes, by improving the sensitivity to insulin mainly in the muscles, fat cells and the liver. Biguanides act primarily by reducing the amount of glucose produced by the liver.

In a randomized, double-blind, comparative study, in which the clinical usefulness of biguanides monotherapy was compared with that of Actos/biguanides concomitant therapy, the latter showed a statistically significant difference in improving HbA1c – an indicator of glycemic control – without increasing the risk of hypoglycemia.

In addition to the currently authorized concomitant therapy with sulfonylurea or alpha-GI, this additional indication for Actos of concomitant therapy with biguanides provides a further option to pursue superior glycemic control, the company said.