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news.Takeda Pharmaceutical (Takeda) has submitted an application for additional indications of alogliptin for combination therapy with sulfonylurea and biguanide to the Ministry of Health, Labour and Welfare in Japan.
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Alogliptin (once daily dosing) was discovered by Takeda’s wholly-owned subsidiary Takeda San Diego and is a member of the dipeptidyl peptidase IV (DPP-4) inhibitors class. DPP-4 selectively metabolizes the insulin-increasing GLP-1 and GIP. By maintaining the blood levels of GLP-1 and GIP, DPP-4 inhibitors lower the blood glucose level.
If approved, the additional indications will enable Takeda to provide more treatment options to healthcare providers for their patients with diabetes mellitus. Takeda already markets Actos, Basen and Gulfast in Japan and continues further research and development activities for additional treatment options in this therapeutic area.
Takeda has also submitted a new drug application (NDA) for alogliptin monotherapy and a combination therapy with a-glucosidase inhibitor in September 2008, and a supplemental NDA for combination therapy with thiazolidinedione in June 2009.
In addition, a NDA for a fixed-dose combination tablet of alogliptin with pioglitazone HCl was also submitted in June 2009. The applications are currently being reviewed by the Ministry of Health, Labour and Welfare.