BioCentury
ARTICLE | Clinical News

FDA panel backs Takeda's gout drug Uloric for some patient populations

January 25, 2019 8:55 PM UTC

A joint FDA advisory panel voted 19-2, with one abstention, that gout drug Uloric febuxostat has a favorable benefit-risk profile for some patient populations. The U.S. business unit of Takeda Pharmaceutical Co. Ltd. (Tokyo:4502) markets Uloric in the U.S. to treat hyperuricemia in gout patients. Takeda did not disclose the specific patient populations.

The FDA panel met to discuss data from the seven-year postmarketing CARES trial to evaluate cardiovascular safety of Uloric vs. allopurinol in gout patients. Uloric met CARES' primary endpoint of non-inferiority to allopurinol in the rate of major adverse cardiovascular events, including CV death, non-fatal myocardial infarction (MI), non-fatal stroke and unstable angina with urgent coronary revascularization. There was a higher rate of CV death, a secondary endpoint, in patients who received Uloric. All other individual MACE rates were similar across treatment arms...

BCIQ Company Profiles

Takeda Pharmaceutical Co. Ltd.