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Nesina

Generic name: alogliptin
Treatment for: Type 2 Diabetes

Update: Nesina (alogliptin) Now FDA Approved - January 25, 2013

Cardiovascular Outcomes Trial for Alogliptin

Takeda Initiates Cardiovascular Outcomes Trial for Alogliptin, An Investigational Treatment for Type 2 Diabetes

DEERFIELD, Ill. and OSAKA, Japan, Aug. 28 /PRNewswire/ -- Takeda Pharmaceutical Company Limited ("Takeda") and Takeda Global Research & Development Center, Inc., a wholly owned United States (U.S.) subsidiary, today jointly announced that the latter has received notification that the U.S. Food and Drug Administration (FDA) has agreed to the study design for a cardiovascular (CV) outcomes trial titled EXAMINE (EXamination of CArdiovascular OutcoMes: AlogliptIN vs. Standard of CarE in Patients with Type 2 Diabetes Mellitus and Acute Coronary Syndrome) for alogliptin, a selective dipeptidyl peptidase IV inhibitor under investigation for the treatment of type 2 diabetes as an adjunct to diet and exercise.

The alogliptin New Drug Application (NDA) was submitted in December 2007, and in the complete response for alogliptin dated June 26, 2009, the FDA requested an additional CV safety trial that satisfies the criteria outlined in the December 2008 "Guidance for Industry: Diabetes Mellitus -- Evaluating Cardiovascular Risk in New Antidiabetic Therapies to Treat Type 2 Diabetes." The EXAMINE study is designed to comply with this Guidance.

"Takeda received FDA agreement to the design of the CV study and we are pleased to move forward with the study and collecting additional safety data so that the FDA can continue the review of the alogliptin NDA," said Nancy Joseph-Ridge, M.D., General Manager, Pharmaceutical Development Division. "We are committed to conducting this study to satisfy the CV safety requirements, leading to the enhancement of the product profile of alogliptin. While this trial is dependent on the occurrence of CV events, at this point we anticipate that we will be able to submit interim results to the FDA approximately two years after the study begins that will meet the FDA Guidance criteria for drug approval."

  Outline of the EXAMINE Trial

  Title:             A Multicenter, Randomized, Double-Blind, Placebo-
                     Controlled Study to Evaluate Cardiovascular Outcomes
                     Following Treatment with Alogliptin in Addition to
                     Standard of Care in Subjects with Type 2 Diabetes and
                     Acute Coronary Syndrome

  Study Start:       September 2009

  Study Completion:  December 2014

  No. of Patients:   Approximately 5,400

  Primary Outcome:   Time from randomization to the occurrence of the
                     Primary Major Adverse Cardiac Events defined as
                     a composite of cardiovascular death, nonfatal
                     myocardial infarction and nonfatal stroke

  Secondary Outcome: Time from randomization to the occurrence of the
                     Secondary Major Adverse Cardiac Events defined
                     as a composite of cardiovascular death, nonfatal
                     myocardial infarction, nonfatal stroke and urgent
                     revascularization due to unstable angina

  Study Sites:       Approximately 1,000 sites in the U.S., Europe, Asia

  About 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 striving toward better health for individuals and progress in medicine by developing superior pharmaceutical products. Additional information about Takeda is available through its corporate Web site, www.takeda.com.

About 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 treatments and seek to bring innovative products to patients through a pipeline that includes compounds in development for diabetes, cardiovascular disease, gastroenterology, neurology and other conditions. Takeda is committed to striving toward better health for individuals and progress in medicine by developing superior pharmaceutical products. To learn more about these Takeda companies, visit www.tpna.com.

Posted: August 2009

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