DEERFIELD, Ill., July 22, and OSAKA, Japan, July 23 /PRNewswire/ -- Takeda Pharmaceutical Company Limited ("Takeda") today announced that Takeda Global Research & Development Center, Inc., a wholly owned United States (U.S.) subsidiary, received notification from the U.S. Food and Drug Administration (FDA) that the FDA extended the review of the New Drug Application (NDA) for the fixed-dose combination (FDC) of alogliptin and ACTOS((R)) (pioglitazone HCl). The new Prescription Drug User Fee Act (PDUFA) date for the FDC is September 4, 2009.
The NDA for the FDC of alogliptin and ACTOS was submitted in September 2008, following the NDA submission of alogliptin monotherapy in December 2007. On March 6, 2009 the FDA informed Takeda that based on the December 2008 FDA Guidance titled, "Guidance for Industry: Diabetes Mellitus -- Evaluating Cardiovascular Risk in New Antidiabetic Therapies to Treat Type 2 Diabetes," the amount of existing alogliptin clinical data in the alogliptin monotherapy NDA was not sufficient to meet certain statistical requirements outlined in that Guidance. On June 26, the FDA asked Takeda to conduct an additional cardiovascular safety trial that satisfies the December 2008 FDA Guidance for alogliptin.
About ACTOS((R)) (pioglitazone HCl)
ACTOS is a prescription medication used with diet and exercise to improve blood sugar (glucose) control in adults with type 2 diabetes. ACTOS is not for patients with type 1 "juvenile" diabetes or diabetic ketoacidosis. ACTOS has not been studied in children and is not recommended for children under the age of 18. ACTOS may be taken alone or with a sulfonylurea, metformin, or insulin.
Important Safety Information About ACTOS
ACTOS is not for everyone. Certain patients with heart failure should not start taking ACTOS. ACTOS can cause new, or worsen, heart failure. Talk to your doctor immediately if you experience unusually fast weight gain, fluid retention (swelling), shortness of breath, or unusual tiredness.
Do not take ACTOS if you have active liver disease. Your doctor should perform a blood test to check for liver problems before you start ACTOS and periodically thereafter. Talk to your doctor immediately if you experience nausea, vomiting, stomach pain, tiredness, loss of appetite, dark urine, or yellowing of the skin.
If you are of childbearing age, talk to your doctor before taking ACTOS, as it could increase your chance of becoming pregnant. Talk to your doctor if you are pregnant, planning to become pregnant, breastfeeding, or planning to breastfeed. When taking ACTOS with insulin or sulfonylureas, you may be at risk for low blood sugar. Some people taking ACTOS may experience flulike symptoms, mild-to-moderate swelling of legs and ankles, anemia, and weight gain. Patients with diabetes should have regular eye exams. If you experience vision problems, consult your doctor immediately. Some patients have experienced visual changes while taking ACTOS.
Some people, particularly women, are at higher risk of having bone fractures while taking ACTOS. Other side effects may include cold-like symptoms, headache, sinus infection, muscle pain, tooth disorder, and sore throat.
Please visit the Takeda Pharmaceuticals North America, Inc. Web site at www.tpna.com for Complete Prescribing Information including the boxed warning about heart failure.
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.
|SOURCE Takeda Pharmaceutical Company Limited|
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