Takeda Submits New Drug Application in the U.S. for Investigational Type 2 Diabetes Therapy, Fixed-Dose Combination Alogliptin/Metformin

OSAKA, Japan and DEERFIELD, Ill., Nov. 23, 2011 /PRNewswire/ -- Takeda Pharmaceutical Company Limited (Takeda) announced today that its wholly-owned subsidiary Takeda Global Research & Development Center, Inc., U.S., submitted a New Drug Application (NDA) to the United States (U.S.) 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., U.S. "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 U.S. 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 greater than or equal to 5 percent 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.

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 it. 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, 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.

Takeda Pharmaceuticals North America, Inc. and Takeda Global Research & Development Center, Inc.

Based in Deerfield, Ill., Takeda Pharmaceuticals North America, Inc. and Takeda Global Research & Development Center, Inc. are subsidiaries of Takeda Pharmaceutical Company Limited, the largest pharmaceutical company in Japan. The respective companies currently market oral diabetes, insomnia, rheumatology, and gastroenterology and cardiovascular treatments and seek to bring innovative products to patients through a pipeline that includes compounds in development for metabolic and cardiovascular disease, gastroenterology, neurology and other conditions. To learn more about these Takeda companies, visit www.tpna.com.

Takeda Pharmaceutical Company Limited

Located in Osaka, Japan, Takeda is a research-based global company with its main focus on pharmaceuticals. As the largest pharmaceutical company in Japan and one of the global leaders of the industry, Takeda is committed to strive towards better health for patients worldwide through leading innovation in medicine. Additional information about Takeda is available through its corporate website, www.takeda.com.

SOURCE Takeda Pharmaceutical Company Limited