Small treatment effect/benefit???…I am not sure about this. Yes, absolute magnitude was small, due to low frequency of the flares during 16 weeks (one flare per subject for 16 weeks). Maybe REGN chose “too healthy” population for Arcalyst prophylaxis? Maybe the criteria for enrolling subjects were too weak?? I will agree with REGN that 16 weeks was sufficient prophylaxis time, so have no idea why is FDA changing view? Extend treatment??? Increase in flares, post 16 weeks? Rebound in IL-1b? FDA statement that flare frequency after treatment period (16-20 weeks) was higher in Arcalyst groups (study 816) is pure BS by FDA, because suddenly placebo group has cut flare rate by >50%. However, there is increase in flare frequency after 16 weeks, so efficacy of the Allopurinol (inadequate response to Allopurinol) should be questioned, not extended prophylaxis.
Regards the new safety study (12 months), “The Agency responded that it would be difficult to consider approving a BLA that has a gap such as this in the safety data.”
I have no idea why was REGN so “stubborn” not to run safety study for 32 weeks (6 months)?
Malignancy…after few doses (lowest is 3)??? Arcalyst should be characterized as “very carcinogenic agent” and immediately removed from market! IF FDA believe in their hypothesis.
PS: Overal, they have very good chance with AC, IMO. |
