Replies to post #158214 on Biotech Values

[piggerpig]

Presumably they have quite a bit of safty data from
The unssuccesful diabetes trials. They have given the drug
To quite a few people by now. Wouldnt the infection problem
Come up by now if it was a show stopper?

[DewDiligence]

…the pursuit of acne seems like an odd waste of time given the FDA's stance and the ilaris results?

Gevokicumab will certainly be safer than Accutane, which is the only approved treatment for severe acne that really works.

[jq1234]

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.