The FDA has issued a complete response letter to Japanese drug-maker Takeda Pharmaceutical regarding New Drug Applications (NDAs) for alogliptin and fixed-dose combination (FDC) alogliptin and pioglitazone.
Recently, Takeda provided postmarketing data from outside the U.S., and has been in discussion with the FDA. The FDA has requested additional data which Takeda believes it can supply to the Agency from postmarketing data from outside the U.S., as well as data from its ongoing clinical trial program.
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 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 and pioglitazone is an FDC therapy, which combines alogliptin and pioglitazone in a single tablet, in development for the treatment of type 2 diabetes in adults as an adjunct to diet and exercise. Pioglitazone is a TZD that directly addresses 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 2 diabetes as an adjunct to diet and exercise. An NDA for the alogliptin and pioglitazone FDC was approved in July 2011 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 LIOVEL in this market.
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