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Takeda Resubmits New Drug Applications to the United States Food and Drug Administration for Alogliptin and the Fixed-Dose Combination Alogliptin and Pioglitazone
Date:7/27/2012

egulating blood glucose levels. The FDC alogliptin and pioglitazone combines two complementary agents with distinct mechanisms of action and, if approved, will be the first type 2 diabetes treatment option in the U.S. to include both a DPP-4i and the thiazolidinedione (TZD) pioglitazone in a single tablet. Pioglitazone-containing medicines have been available in the U.S. since 1999 for the treatment of type 2 diabetes as an adjunct to diet and exercise.

The most common adverse events (greater than or equal to 5% and greater than placebo) reported in the alogliptin phase 3 program include headache, urinary tract infection, nasopharyngitis, and upper respiratory tract infection. With regard to the co-administration of alogliptin and pioglitazone, common adverse events (greater than or equal to 5%) reported include nasopharyngitis, back pain, urinary tract infection, and influenza.

About Type 2 Diabetes

Type 2 diabetes is the most common form of diabetes and has reached epidemic proportions globally. In fact, more than 23 million Americans currently live with the disease. Type 2 diabetes is a progressive and chronic condition and patients should work with a health care professional to manage and monitor their disease. In addition to diet and exercise, patients often need to take multiple medications in order to help them manage their blood glucose levels. The global health care expenditures for diabetes (both type 1 and 2) were estimated at $376 billion in 2010. By 2030, this number is projected to exceed $490 billion.

About Alogliptin and Alogliptin and Pioglitazone

Alogliptin is a DPP-4i being investigated in the U.S., as an adjunct to diet and exercise, for the treatment of type 2 diabetes. DPP-4 inhibitors address insulin deficiency by slowing the inactivation of incretin hormones GLP-1 and GIP. As a result, an increased amount of active incretins enables the pancreas to secrete insulin in a glucose-dependent manner, thereby assi
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SOURCE Takeda Pharmaceutical Company Limited
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