FDA has not completed routine investigator site and CRO vendor inspections
Osaka, Japan, January 19, 2009 –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 FDA will not be able to complete its review of the febuxostat New Drug Application (NDA) by the Prescription Drug User Fee Act (PDUFA) date of January 18, 2009.
“The FDA raised no issues with the NDA submission or the data included in it, rather FDA stated that due to its inability to complete routine inspections at investigator sites and at a Clinical Research Organization vendor involved in the development of febuxostat, the PDUFA date for febuxostat would be missed by the FDA," said Dean Sundberg, senior vice president, regulatory affairs at Takeda Global Research & Development Center, Inc. "Takeda has taken all necessary steps and provided all necessary information at this point in the NDA review process and we await FDA’s completion of these routine inspections and look forward to receiving a final approval date for febuxostat."
Febuxostat is currently under review with FDA for once-daily, oral treatment of hyperuricemia in patients with gout. The NDA for febuxostat included data from multiple clinical trials involving more than 4,000 patients. In November 2008, FDA's Arthritis Advisory Committee recommended febuxostat for approval by a vote of 12-0 with one panel member abstaining. Takeda licensed febuxostat from Teijin Pharma Limited (Teijin Pharma), based in Tokyo, Japan.
About Takeda Pharmaceutical Company Limited
Located in Osaka, Japan, Takeda (TSE:4502) 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 website, www.takeda.com.
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 and gastroenterology treatments and seek to bring innovative products to patients through a pipeline that includes compounds in development for diabetes, cardiovascular disease, oncology, gastroenterology, neurology, rheumatology 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.