Press Releases
March 25, 2010
Takeda Pharmaceutical Company Limited
Takeda Submits Application in Japan for Additional Indications of
Alogliptin for Combination Therapy with Sulfonylurea and
Combination Therapy with Biguanide
OSAKA, Japan, March 25, 2010 – Takeda Pharmaceutical Company Limited (Takeda) today announced that it submitted an application for additional indications of alogliptin (generic name, development code: SYR-322) for combination therapy with sulfonylurea and combination therapy with biguanide to the Ministry of Health, Labour and Welfare in Japan.
Alogliptin (once daily dosing) was discovered by Takeda’s wholly-owned subsidiary, Takeda San Diego, Inc. 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, these 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 submitted a New Drug Application (NDA) for alogliptin monotherapy and a combination therapy with α-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 (generic name, trade name in Japan: Actos®) was also submitted in June 2009. These applications are currently being reviewed by the Ministry of Health, Labour and Welfare.
[*] GLP-1 (glucagon-like peptide-1) and GIP (glucose-dependent insulinotropic peptide) are excreted in the digestive tract following food intake, and stimulate the beta-cells in the pancreas—thereby stimulating increased insulin secretion—and it has also been confirmed that they improve the functioning of the beta cells themselves.
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