FDA approval for febuxostat. It has been givenNEWS FLASH! FEBRUARY 13 2009 The U.S. FDA has approved febuxostat. It's brand name in the United States is Uloric.
You can read more here, and download prescribing information.
Date of article below: November 26 2008 FDA approval for febuxostat, the new gout drug, received a big boost on November 24 2008 when a specially convened meeting of rheumatology experts, FDA officials and its developers, voted that the FDA should approve use of febuxostat in the United States. Among those at the meeting who were entitled to vote, the vote was reported as 12 – 0 in favour, with one abstention. That's a big majority in favour, but note that the committee proposes but the FDA disposes. In other words the FDA makes the final decision, and FDA approval for febuxostat has not yet happened. If it's approved, its U.S. brand/trade name will be "Uloric". Febuxostat has demonstrated throughout its trials that it is a more powerful inhibitor of xanthine oxidase the enzyme used by the body (mainly in the liver) to convert purines into uric acid. Uric acid, usually at excessive levels, is the underlying cause of gout. Simply put, febuxostat has reduced uric acid levels more quickly, and to a greater extent than allopurinol, (one brand name Zyloprim) the traditional uric acid reducing medication. WHY THE DELAY IN APPROVING FEBUXOSTAT? Its developers, Japanese based Takeda Pharmaceutical Co Ltd., originally applied for FDA approval for febuxostat in 2004. After years of trials and extension trials the FDA asked Takeda to undertake an extra extension trial (Study F-153 aka the CONFIRMS study) because the FDA was not convinced it is as safe as allopurinol. The main concern was a small number of various kinds of heart attacks, a few of which led to death in earlier trials but which were higher than those trialing allopurinol. Heart problems are linked with gout so any drug's effect on the heart is very important. And analysis among patients with mild or moderate kidney problems, medically called renal impairment, Febuxostat at 40 mg and 80 mg doses was found to be superior to allopurinol in patients with renal impairment. A few days before the special meeting, the FDA released a public briefing document that said the latest data did NOT indicate heart risks from febuxostat at 40 mg and 80 mg doses were greater than with allopurinol. Its earlier concerns had been allayed by the results of the large extension trial.The FDA is probably satisfied with any other doubts it may have had, because the real questions asked of the committee were: Does it have cardiovascular safety and is it effective at doses of 40 mg or 80 mg? i.e. do the benefits out weigh the risks; do gout patients with mild/moderate kidney problems need it and is it safe for them? Should post marketing studies be done in respect of various heart problems? If the FDA had other doubts it would probably have asked the committee to examine them. And the FDA itself had said that it was satisfied that febuxostat is as safe as allopurinol. So the committee has voted in favour, and for post marketing studies. But the FDA does not always approve medicines that committees, however well informed, think should be approved. Both Takeda and the FDA made presentations to the special committee. If you want more details about febuxostat, Takeda presented a 167 page document in favour of its approval,
which you can download here. At the FDA's home page enter "Febuxostat" into the search box and on the page that arrives it's the first document
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