WebMD Medical News
Louise Chang, MD
Feb. 16, 2009 -- The FDA has approved Uloric, the first new gout drug in
more than 40 years, according to Uloric's maker, Takeda Pharmaceuticals.
Uloric, taken once daily by mouth, is approved for the chronic management of
hyperuricemia (elevated levels of uric acid) in gout patients.
Uloric works by blocking an enzyme called xanthine oxidase, which helps
prevent uric acid production, lowering elevated uric acid levels, according to
In 2005, the FDA refused to approve Uloric because there were slightly more
deaths and heart problems in patients taking the drug than in patients taking
allopurinol, another gout drug. As people with gout problems already are at
higher risk of heart disease, the FDA issued an "approvable" letter,
noting that Uloric could be approved if this safety question were
Takeda resolved the safety question by performing a large new phase III
clinical trial that enrolled more gout patients than the two previous phase III
trials combined. The new study found no more deaths and no more heart problems
in patients taking Uloric than in patients taking allopurinol.
Based on those results, an FDA advisory committee recommended Uloric's
approval in November
2008. The FDA often follows the recommendations of its advisory committees,
but it's not obligated to do so.
The most commonly reported adverse events in Uloric's clinical trials were
liver function abnormalities, nausea, joint pain, and rash, according to Takeda
SOURCES:News release, Takeda Pharmaceuticals.WebMD Health News: "New
Gout Drug Gets FDA Panel Nod."
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