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Last updated on April 18, 2014 at 17:24 EDT

Takeda Announces PDUFA Action Date for Investigational Type 2 Diabetes Therapies Alogliptin and the Fixed-Dose Combination Alogliptin/Pioglitazone

November 1, 2011

DEERFIELD, Ill., Nov. 1, 2011 /PRNewswire/ – Takeda Global Research & Development Center, Inc., (Takeda) announced that the U.S. Food and Drug Administration (FDA) has assigned a Prescription Drug User Fee Act (PDUFA) action date of January 25, 2012 for the review of its investigational type 2 diabetes therapy alogliptin, and the fixed-dose combination therapy alogliptin/pioglitazone, which combines alogliptin with pioglitazone in a single tablet.

Currently, the FDA is reviewing the new drug applications (NDA) for the investigational therapies, which were resubmitted on July 25, 2011; the FDA has categorized these as Class 2 responses, requiring up to six months for review.( )Alogliptin is a selective dipeptidyl peptidase IV inhibitor (DPP-4i) under investigation in the United States (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 a role in regulating blood glucose levels. Pioglitazone was approved in 1999 for the treatment of type 2 diabetes as an adjunct to diet and exercise. If approved, alogliptin/pioglitazone will be the first type 2 diabetes treatment option in the U.S. to include both a DPP-4 inhibitor and a thiazolidinedione (TZD) in a single tablet.

According to the International Diabetes Federation, a staggering 285 million individuals were living with diabetes worldwide in 2010.

“As recent figures indicate that diabetes continues to be a serious global health challenge, Takeda remains deeply committed to researching new and important therapeutic options for patients living with type 2 diabetes,” said David Recker, M.D., senior vice president, clinical science, Takeda Global Research & Development Center. “Phase 3 studies have demonstrated that the combination of alogliptin with pioglitazone produced significant improvements in glycemic control, as compared to individual monotherapy. If approved, alogliptin/pioglitazone will be the first type 2 diabetes therapy in the U.S. to combine a DPP-4 inhibitor with a thiazolidinedione in a single tablet.”

Common adverse events (greater than or equal to 5%) identified in the alogliptin phase 3 program included headache, urinary tract infection, nasopharyngitis, and upper respiratory tract infection. In the alogliptin/pioglitazone phase 3 program, the common adverse events (greater than or equal to 5%) identified included 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. Almost 26 million Americans currently live with 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 and prevent diabetes and 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, 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 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.

SOURCE Takeda Global Research & Development Center, Inc.


Source: PR Newswire