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Re: iwfal post# 158252

Wednesday, 03/13/2013 2:58:42 PM

Wednesday, March 13, 2013 2:58:42 PM

Post# of 257273

but to first order Ilarus is the most similar of the IL-1 drugs to Xoma's. Same target (IL-1b) and same half life (about 21 days).



Look at the clinical profiles of the two drugs, they are the least similar among the 4 IL-1 drugs. There are plenty of data out there.

Yes, the Ilaris trial was for acute treatment of a flare, but gout flares are 'chronic' (i.e. repeat forever).



Not true! For high risk patients, yes. For majority patients, they might have many flares over very long period of time, but they aren't frequent enough to be true "chronic" sense. There was discussion of whether Ilaris could be approved for very high risk patients.

An associated label, if strictly followed, would probably result in more treatment by Ilaris than the 16 week-during-initiation-of-allopurinol label for the treatment with Arcalyst.



I don't agree. Panels don't agree with your assessment either. Allopurinol initiation patient population is quite large, treatment period much longer. 16-week trial in that setting isn't adaquate.

The panel voted unanimously 11-0 stating Regeneron’s clinical trials were too short to prove the treatment was safe, or that it would help patients over time. The treatment is meant to be taken for 16 weeks along with a combination of other drugs.







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