The #avacopan story in #ANCA vasculitis is messy. IMHO #Amgen should be forced to withdraw & do another registrational trial. If not, they should be forced to do a PASS under a REMS. Finally was ava rolled out in Japan during a high #covid period -> VBS was due to virus+/-drug?
The #avacopan story in #ANCA vasculitis is messy. IMHO #Amgen should be forced to withdraw & do another registrational trial. If not, they should be forced to do a PASS under a REMS.
Finally was ava rolled out in Japan during a high #covid period -> VBS was due to virus+/-drug?
more h/t @[email protected] www.fda.gov/drugs/drug-a... accusations of selectively re-adjudicating with an intent to p-hack #Avacopan #Tavneos

CDER proposes to withdraw appr...
CDER proposes to withdraw approval of TAVNEOS

CDER proposes to withdraw approval of TAVNEOS

U.S. Food and Drug Administration
As @[email protected] sez (on the other site) given limited efficacy benefit anyways - #avacopan is now dead until proven otherwise Stop using it