FDA approval for febuxostat





The date of the original article below, FDA approval for febuxostat, was November 26 2008. It was last reviewed, or updated, on December 15 2017

Febuxostat, the new gout drug, received a big boost on 24 November 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 (favor), with one abstention. That's a big majority in favour (favor).

However, the committee proposes, but the FDA disposes. The FDA does not always approve medicines that committees, however well informed, think should be approved. Nevertheless, just over a couple of months later FDA approval for febuxostat was given.

Its U.S. and Canadian brand name is 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, used since 1963.

WHY THE DELAY IN APPROVING FEBUXOSTAT? 

Its inventors and developers are Japanese based Teijin Pharma Ltd., who have licensed it in North America to Takeda Pharmaceuticals America Inc. Takeda originally applied for FDA approval for febuxostat in 2004. 

After years of trials and extension trials, in around 4,000 patients - the largest ever study of a new gout drug - the FDA asked Takeda to undertake an extra extension trial (Study F-153 aka the CONFIRMS study). 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. 

The extra extension trial, (F-153), with more study patients than in any previous trial, was completed. An enormous amount of analysis was done on all the heart data for both the latest and earlier data. 

Kidney problems In 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 lowering uric acid below the crucial level. This was excellent news. If you have mild to moderate kidney disease your doctor will probably prescribe it at the same dosage as if your kidneys were healthy. But if you have moderate to severe kidney disease it would be prescribed with great caution.

Heart disease 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. Nevertheless, it can only be prescribed for people with heart disease with great caution, and regular monitoring.

At the time of the committee hearing, the FDA was 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?

The answer was yes to all three. 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. 

Uloric (febuxostat) has been successful in lowering uric acid to the crucial 6.0 mg/dL, and below, level. But not for everyone, so you can't be certain it will work well enough.

You will get a great psychological boost if you test your serum (blood) uric acid level regularly and watch it falling. And useful knowledge if you learn that it isn't. See your doctor for this test, or click on this link to learn about the UASure uric acid test kit you can use at home.

If you test at home, tell your doctor you are doing this, and get your results confirmed by him/her to ensure you are doing it correctly.

U.S.Dosage  40 mg or 80 mg daily. Subject to your doctor's final decision, elderly patients can take it. So can patients with mild to moderate liver problems. But it would only be prescribed with great caution if you have severe liver problems. For kidney disease patients - see the copy above. And for pregnant and nursing mothers - only with great caution too.

It is not known if febuxostat is safe and effective in children under 18 years old.

You can take it with, or without food. It can be taken on a diet.

It can be taken with these medicines, without changing the dose: 

Colchicine - halts gout attacks.

Naproxen - an NSAID used to relieve gout pain.

Indomethacin - perhaps the best NSAID for relieving gout pain.

Hydrochlorothiazide - a thiazide diuretic. Its main use is to reduce high blood pressure.

Warfarin - helps prevent blood clots

Desipramine - an anti-depressant.

Antacids - neutralise acids, especially in the stomach.

Febuxostat should lower uric acid by a considerable amount in only 24 hours. If uric acid doesn't fall to the target 6.0 mg/dL (0.357 mmol/l) or lower in two weeks, the dose can be increased from 40 mg to 80 mg daily.

Restrictions  In the U.S., Canada, and most other countries Uloric (aka Adenuric, Feburic) is not prescribed for patients with high uric acid (hyperuricemia) but no history of gout. You must have high uric acid AND a history of gout. Ask you doctor about this. It won't be prescribed for patients whose cause of gout is Lesch Nyhan syndrome or transplant surgery.

Contraindications  Usage is inadvisable in patients who may need Azathioprine - used to suppress the immune system. (Some brand names Azasan, Imuran). And Mercaptopurine - used to treat certain kinds of leukemia. (One brand name: Purinethol).

Use with great caution if taking Theophylline - a bronchial dilator which relaxes muscles in the lungs and chest. Used for asthma, bronchitis and emphysema. 

Of course, report side effects to your doctor as soon as possible. Main side effects are listed on our second febuxostat page. In the prescribing information at the Uloric website - see the link below - there's a list of side effects, common and those affecting less than 1% of trial patients

Visit Uloric's official website here and download prescribing information

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 (favor)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  

Related pages

We have more to say about febuxostat on this page. And there is a list of countries that have approved it.

Our own look at febuxostat's effectiveness, based on the published EMEA (European Medicine Agency) findings, can be read here.




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