I see your approach, however the target population is indifferent until they not include ‘to reduce risk of coronary heart disease.’
The FDA’s problem with the indication is the TG level (=200 to <500 mg/dL), since according to their view ‘FDA has historically considered granting approval for lipid-altering drugs based on favorable changes in the lipid profile, with the assumption that these changes would translate into a benefit on clinical outcomes.’
‘Dr. Colmam: I also think that if ACCORD Lipid and AIM-HIGH and THRIVE were positive, I think we would have a different discussion today.’ (October 16, 2013, AdCom).
I think that if ACCORD Lipid and AIM-HIGH and THRIVE had not been done we would have a different discussion today.
We have a problem due to the (citied), three negative studies’ interpretation, not because of indication or safety.
Don not forget, since 2008, Trilipix is FDA-approved for use in combination with a statin to reduce TG and increase HDL-C in patients with mixed dyslipidemia and CHD or a CHD risk equivalent who are on optimal statin therapy to achieve their LDL-C goal.
The debate is about that ACCORD Lipid and AIM-HIGH and THRIVE result could be or not extend for Vascepa.
FDA said yes, while I could not find any parameters – except that patients were on statin – that match with ANCHOR.
Parameters / ACCORD-Lipid / AIM-HIGH / THRIVE / ANCHOR
TG > 200 mg/dL / no /no /no / yes
HDL-C < 39 mg/dL / no / no / no / yes
contains EPA / no / no / no / yes
on statin / yes / yes / yes / yes
CD risk reduction / no / no / no / ongoing trial
Furthertmore ‘some members felt there was not enough evidence from the ACCORD-Lipid trial relevant to the specific Trilipix coadministration indication to warrant withdrawal of the indication. Others felt that with no additional relevant clinical evidence provided by ACCORD-Lipid, and because the indication had already been granted based on numerical improvements and supported by regulatory standards of the time, this should be honored until further information on clinical outcomes were available.’ and if we see the subgroups – TG and HDL-C parameters were comparable with ANCHOR’s – ‘we .. have a different discussion today’
It’s unacceptable that the 3 studies – with different parameters - enough to determine that substantial scientific issue essential to determining the efficacy of Vascepa and were not enough to withdrawal of other drug’s indication (specially where they found a safety issue.)
Top of it, it’s also unacceptable that they determined the issue in the BD only, not ANYTIME since the publication of Accord-Lipid or since March 2013 when the latest FDA’s reason was published.
