Takeda Global Research & Development Center, Inc., a wholly-owned subsidiary of Takeda Pharmaceutical Company Limited (Takeda) has submitted a New Drug Application (NDA) to the US Food and Drug Administration (FDA) for the fixed-dose combination therapy alogliptin/metformin, which combines alogliptin with metformin in a single tablet. The FDA is expected to review the NDA submission within the next ten months, the standard review period for a new application.
“This NDA submission further extends Takeda’s commitment to offering patients with type 2 diabetes a range of therapeutic options to help them manage their condition,” noted Thomas Strack, M.D., vice president, clinical science, Takeda Global Research & Development Center, Inc., US. “The worldwide incidence of type 2 diabetes continues to expand at a rapid rate and we continue our research into additional medications to treat these patients.”
Alogliptin is a selective dipeptidyl peptidase IV inhibitor (DPP-4i) under investigation in the US for the treatment of type 2 diabetes as an adjunct to diet and exercise. Discovered by Takeda San Diego, Inc., alogliptin is designed to slow the inactivation of incretin hormones GLP-1 (glucagon-like peptide-1) and GIP (glucose-dependent insulinotropic peptide), which play roles in regulating blood glucose levels. Metformin is a widely-used diabetes medication that acts primarily by reducing the amount of glucose produced by the liver. These medications work in combination to help patients with type 2 diabetes manage their blood glucose levels.
Common adverse reactions reported in =5 per cent of patients treated with co-administration of alogliptin with metformin were: upper respiratory tract infection, nasopharyngitis, creatinine renal clearance decreased, diarrhea, headache, hypertension, and urinary tract infection.
Alogliptin is a DPP-4i being investigated, 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 thiazolidinedione that directly targets insulin resistance, a condition in which the body does not efficiently use the insulin it produces to control blood glucose levels. It is approved in adults for the treatment of type 2 diabetes as an adjunct to diet and exercise. An NDA for the alogliptin/pioglitazone fixed-dose combination 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.