| HOME >> BIOLOGY >> TECHNOLOGY |
First new treatment option in more than 40 years, marking second FDA approval for Takeda within one month
DEERFIELD, Ill., and OSAKA, Japan, Feb. 13 /PRNewswire/ -- Takeda Pharmaceutical Company Limited and its wholly-owned subsidiary, Takeda Pharmaceuticals North America, Inc., announced today that the United States Food and Drug Administration (FDA) has approved ULORIC(R) (febuxostat) 40 mg and 80 mg for the chronic management of hyperuricemia in patients with gout. This once-daily, oral medication is the first new treatment option in more than 40 years for the more than five million patients who have hyperuricemia associated with gout. ULORIC was discovered by Teijin Pharma Limited (Teijin Pharma) of Tokyo and licensed to Takeda for the U.S. market.
"The approval of ULORIC offers clinicians and their patients who have hyperuricemia associated with gout a new treatment option that helps prevent uric acid production," said Nancy Joseph-Ridge, M.D., president, Takeda Global Research & Development Center, Inc., U.S. "In the years that we've dedicated to studying patients who have gout, I know that many patients go to their doctor during a flare not understanding that gout is a chronic disease that needs to be managed on a long-term, daily basis."
Experts recognize that a goal in the treatment of chronic gout is the reduction and maintenance of serum uric acid levels of less than 6 mg/dL. ULORIC, a xanthine oxidase inhibitor, effectively lowers levels of serum uric acid in patients with hyperuricemia associated with gout. It was studied and evaluated in multiple clinical trials involving more than 4,000 subjects, in some for up to five years.
The largest, pivotal, phase 3 clinical trial, CONFIRMS, demonstrated that ULORIC 80 mg was superior to ULORIC 40 mg and allopurinol 300/200 mg (67 percent, 45 percent and 42 percent, respectively) at achieving the primary end point of serum uric acid
'/>"/>
| SOURCE Takeda Pharmaceutical Company Limited Copyright©2009 PR Newswire. All rights reserved |
Related biology technology :
1. FDA Approves Clinical Studies of a Novel Anti-Cancer Drug Developed by Italian Researchers
2. FDA Approves KAPIDEX(TM) (Dexlansoprazole) delayed release capsules for the Treatment of GERD
3. Bion Announces PENNVEST Board Approves $7.8 Million Financing for Kreider Farms Dairy Project
4. Monsanto Board Approves 10 Percent Dividend Increase
5. FDA Approves Most Comprehensive System to Test Donated Blood for HIV, Hepatitis B & Hepatitis C
6. MultiVu Video Feed: U.S Food and Drug Administration (Fda) Approves Latisse(TM) --
7. FDA Approves Boston Scientifics Express(R) SD Renal Stent System
8. AUDIO from Medialink and GlaxoSmithKline: FDA Approves Boostrix for Adults
9. FDA Approves Boston Scientifics Apex(TM) PTCA Dilatation Catheter
10. FDA Approves Ranexa(R) for First Line Anti Anginal Use and Adds New Claims for Reduction of Ventricular Arrhythmias, Bradycardia, New Atrial Fibrillation and HbA1c
11. FDA Approves Additional Indication for Norditropin(R) for Small for Gestational Age (SGA) in Children
| Copyright © 2003-2012 Bio-Medicine. All rights reserved. ABOUT | CONTACT US | DISCLAIMER | PRIVACY POLICY | TERMS AND CONDITIONS |  |