Replies to post #223943 on Amarin Corp Plc (AMRN)

[Whalatane]

Atom

re
It is an "or." REDUCE-IT (hyperlink) had two populations,

1. 29.3% on the basis of primary prevention (i.e., patients had diabetes mellitus and at least one additional risk factor)
2. 70.7% were enrolled on the basis of secondary prevention (i.e., patients had established cardiovascular disease)

The secondary prevention showed greater benefit than the primary prevention population (27% vs 12% RRR, hyperlink). Therefore, you can't expect the FDA to lump them together under the same label.....my emphasis .
--------------------
Say what ?....Both groups had significant RRR ..yes one more than the other but you really expect the FDA to say to the primary prevention diabetics ...no no ...not for you ..12% RRR is not good enough ?

Kiwi

[chas1232123]

The concern about primary prevention possibly being omitted from the Vascepa label is unfounded. All SPA requirements have been met, and there is no reason to expect this SPA to be rescinded.

Note that, as Prof Bhatt mentioned in his recent video, primary prevention subgroup had 2 year delay before benefits kicked in, vs about 1 year for secondary prevention. Adjusting for the trial underestimation of RRR due to startup effect would increase the primary prevention RRR from 12% to about 20% (factor of 4.9/(4.9-2)). Secondary prevention RRR was also underestimated, but not by as much. And, as Pharmacydude pointed out the other day, RRR of 6% was approved and is in wide use for Ezetrol.

We're in good shape.