Amarin Corp Plc (AMRN)

[Laurent Maldague]

Much appreciated. It does seem like this is possible. FDA could grant accelerated approval, but conditional on Amarin launching a larger outcomes trial. I think that would be the best case scenario here. We'd probably need a larger outcomes trial anyway for EMA/European approval.

"Lilly had applied for accelerated approval last year based on findings from a small mid-stage study of around 250 people with Alzheimer’s, half of whom received donanemab. The study showed treatment with the drug eliminated toxic clumps of a protein known as amyloid that’s long been seen as central to Alzheimer’s disease. Encouragingly, results also indicated that patients on donanemab declined more slowly than those on a placebo."


Donanemab was eventually approved based on the TRAILBLAZER-ALZ 2 (N=1800).

https://www.biopharmadive.com/news/fda-reject-lilly-donanemab-alzheimers-drug-accelerated-approval/640819/