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Re: iwfal post# 158214

Wednesday, 03/13/2013 1:22:56 PM

Wednesday, March 13, 2013 1:22:56 PM

Post# of 257580
IL-1 does have infection risk, but IL-1 drugs are not the same. Ilaris serious infection risk is high after just one single injection possibly because the drug stays in the body for long period of time. Arcalyst infection rate is high, but serious infection rate isn't. The other approved IL-1 drug Kineret in RA has much better safety profile. Gevokizumab doesn't have similar clinical profile to Illaris and Arcalyst to me. It had 6-month trial data in T2D.

In addition, Arcalyst's rejection in Gout wasn't due to safety alone. The drug failed in acute Gout flare, same indication Ilaris was rejected, thus seeking Gout flare prevention indication with only short term trial of 16 weeks. Safety requirement for prevention is much higher.

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