This is the latest stage to try and get approval for the second new gout drug this year.
Hot on the heals of Uloric, the US brandname for febuxostat, pegloticase (formerly known as PEG-uricase) seeks release under Savient’s brand new name of Krystexxa.
FDA review has been postponed from February to give time for additional analysis of cardiovascular risks.
So what does this mean for gout sufferers?
Assuming approval is given, do not be thinking that you have a newer, easier option for controlling your uric acid.
Krystexxa cannot be taken orally. You get dosed up every two weeks with 8mg delivered by intravenous injection.
As well as being inconvenient, there are fairly high documented reaction rates. On a positive side, it is good that severe gout sufferers have an alternative if they cannot tolerate allopurinol.
So expect plenty drug company stimulated hype over the next few weeks. It is such a pity that similar money and exposure does not go into fixing the two great fallacies inherent in healthcare regimes throughout the world:
- Gout sufferers need better diagnosis. Too many patients are dismissed without gout because “normal” uric acid range is set too high.
- Allopurinol is rarely prescribed properly. Most gout patients do not get the right dose, the right monitoring, or the right support.
For latest information, please see the Krystexxa (pegloticase) guidelines.
Krystexxa HAS been approved and as of this writing will launch in 2-3 weeks
Thank you AJ.
Do you have any references for this? I would have expected a bit more publicity from the manufacturers, and I cannot find anything on the FDA site (though experience tells me that updates there can take some time to be published)
FDA NEWS RELEASE
For Immediate Release: Sept. 14, 2010
Media Inquiries: Karen Riley, 301-796-4674,
Consumer Inquiries: 888-INFO-FDA
FDA approves new drug for gout
The U.S. Food and Drug Administration today approved Krystexxa (pegloticase) to treat the painful condition known as gout in adults who do not respond to or who cannot tolerate conventional therapy.
http://www.goutpal.com/1150/krystexxa-no-easy-answer-for-intransigent-gout/
Thank you for that, 606david.
I hope you don’t mind, but I’ve changed your link to my review of the Krystexxa press release, which has a link to the original. I’ll add a complete pegloticase summary soon.