Question-and-Answer Session
Operator
(Operator instructions) And we'll go first to Eric Varma with Leerwink Swann.
Eric Varma – Leerwink Swann
Hey, good morning I had a quick question on a follow-on about febuxostat. If you can just kind of remind us how the CV incidents compare between febuxostat and pegloticase and in addition if you think that febuxostat might be a good use for maintenance therapy for patients who started on pegloticase and then normalized uric acid?
Paul Hamelin
Yes, first of all I would really refer you or suggest that you go back in and listen to the Advisory Committee panel presentation and the cardiovascular adjudication that was presented by Tecadah at that time is a good source of quality information.
I think what was reported at that time was the cardiac adjudication one has to remember is in a totally different population so that if febuxostat trials were in general gout populations which had a far lower cardiovascular risk profile upon study entry than what was in our pegloticase trial group.
So it's hard to compare the cardiac adjudication between the two study groups. Having said that, as you know, there was an imbalance in the febuxostat trials, as well, and despite having an imbalance in that trial the Committee and the agency ultimately approved febuxostat.
So as I mentioned earlier I think that's a positive signal for us as we continue to go through the review process with the FDA on pegloticase.
Eric Varma – Leerwink Swann
And then on using febuxostat potentially as a maintenance after uric acid normalization (inaudible)?
Paul Hamelin
Yes, at this time we've not conducted any trials, you know going into if you will step down or crossover therapies to oral xanthine oxidase inhibitors or anything of that nature. You know our trials were predominantly in I think 82% of the patients in our trials could not take allopurinol because they were medically contraindicated.
So there is no alternative right now. Although to your point maybe some of these patients in the future might be able to tolerate or handle febuxostat after you know a course of therapy on pegloticase or KRYSTEXXA.
Operator
Our next question comes from Salveen Kochnover with Collins and Stewart.
Salveen Kocknover – Collins and Stewart
Thank you for taking my questions. Do you intend to submit any additional amendments to the FDA ahead of a potential upcoming panel and any time points for a potential panel?
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