Posts Tagged uricase

FDA Rejects New Gout Drug and Approve an Old One

It was starting to look like 2009 was the year going banner year for new gout drugs.  That all came to a holt on Sunday as the FDA rejected the application for Savient Pharmaceuticals, Inc.’s drug, Krystexxa® (also called puricase or pegloticase).  This new drug used an enzyme not found in humans that breaks down uric acid in the body.  To prevent the body rejecting the foreign enzyme it is “locked up” in a molecular “cage”.  This cage allowed uric acid to flow in but blocks the immune system from attacking the enzyme (see, New Gout Drugs – Coming to a Pharmacy Near You).

Interestingly, the FDA did not have any complaints about the drug itself and found that the drug was safe and effective.  In fact, the FDA’s advisory board voted 14 to 1 to approve the drug.  However, the FDA raised concerns that the drug that was studied was created using a different manufacturing process than the drug that would be released to the public.  Due to concerns that this different manufacturing process could change the safety or effectiveness of the drug, the FDA rejected the drug until the manufacturer proves that the different manufacturing method resulted in a drug that was also safe and effective.
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New Gout Drugs – Coming Soon to a Pharmacy Near You

On valentine’s day this year, the FDA gave all of us gout sufferer’s a special valentine’s day gift. They approved the first new gout drug in more than forty years. But the good news doesn’t end there. There are several other new gout drugs that are in development.


Febuxostat is the generic name for the drug released on Valentine’s day.  It will be sold on the market under the brand name Ulroic® and is the first new xanthine oxidase inhibitor to be approved since allopurinol.  Xanthine oxidase inhibitors are medications that block the xanthine oxidase enzyme from creating uric acid in the body and thus, lowers uric acid levels.  This medication is chemically very different from allopurinol so it is hoped that people that have had allergic reactions to allopurinol will be able to take Uloric without any problems.  Though there are many documented cases of people that where allergic to allopurinol that have taken febuxostat without any problems, I would still recommend caution if you have had severe reactions to allopurinol — better safe than sorry.  Its best to start this medication at a very low dose and watch for any adverse reactions.
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