Amarin Seeks AMR101 Approval; Hopes To Begin Commercialization Of First Product
This article was originally published in The Pink Sheet Daily
Executive Summary
The New Jersey biotech submitted the NDA for its omega-3 fatty acid drug with FDA.
You may also be interested in...
Amarin Aims Vascepa For The Sweet Spot Of Dyslipidemia
FDA leaves door open to modify label of Amarin’s omega-3 fatty acid therapy Vascepa prior to approval in a healthier population, says company CEO. Per the current label, triglycerides are lowered significantly with no increase in LDL cholesterol, a potential differentiating point from Pronova/Glaxo’s blockbuster EPA/DHA therapy Lovaza.
Amarin’s Vascepa May Give Lovaza A Run For Its Money
Label for Amarin’s EPA-only omega-3 fatty acid therapy notes that in patients with really high triglycerides, triglycerides are lowered significantly with no increase in bad cholesterol, a potential differentiating point from Pronova/Glaxo’s blockbuster EPA/DHA therapy Lovaza. But contrary to what Amarin wanted, data from a study in healthier patients doesn’t make it into labeling.
As It Soaks Up Good Trial Results, Amarin Ponders Partners - Or None
A second set of clinical trial results expands the potential market for AMR101 tenfold, triggering increased investor and partnership interest.