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U.S. Food and Drug Administration (FDA) Delays Review of Takeda's Investigational Type 2 Diabetes Therapies, Alogliptin and Alogliptin/Pioglitazone
Date:11/18/2011

ial outlook, which was announced on November 4, 2011, because of this delay.

About Type 2 Diabetes

Type 2 diabetes is the most common form of diabetes and has reached epidemic proportions globally. More than 23 million Americans currently live with type 2 diabetes, and at least seven million are unaware that they have 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 medication in order to help manage glucose control. The global health care expenditures to treat diabetes and prevent its complications were estimated at $376 billion in 2010. By 2030, this number is projected to exceed $490 billion.

About alogliptin and alogliptin/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 (glucagon-like peptide-1) and GIP (glucose-dependent insulinotropic peptide). As a result, an increased amount of active incretins enables the pancreas to secrete insulin in a glucose dependent manner, thereby assisting in the management of blood glucose levels. An NDA for alogliptin was approved in April 2010 by the Japanese Ministry of Health, Labour and Welfare for the treatment of type 2 diabetes, and the therapy is currently available under the brand name NESINA® in this market.

Alogliptin/pioglitazone is a fixed-dose combination therapy in development for the treatment of type 2 diabetes, which combines alogliptin and pioglitazone in a single tablet. Pioglitazone is a TZD that directly targets insulin resistance, a condition in which the body does not efficiently use the insulin it produces to control blood glucose levels, and is approved in adults for the treatment of type
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SOURCE Takeda Pharmaceutical Company Limited
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