FDA Briefing Documents Point to Label Expansion for Amarin's Vascepa
Posted on November 13, 2019 by Medtech[y] Staff
Shares of Amarin (NASDAQ:AMRN) were up over 20% after the FDA released briefing documents Tuesday morning, which didn't have any of the combative language investors have come to expect in pre-AdCom briefing documents. The briefing documents released by the FDA committee were the first hurdle before Thursday's Endocrinologic and Metabolic Drugs Advisory Committee meeting to discuss Amarin's application for expanded labeling for Vascepa, but the FDA may have tilted their hand by saying the Vascepa has a "favorable benefit/risk profile" for the cardiovascular indication they are seeking.
If approved, analysts have projected the expanded labeling could lead to billions in new sales, which is one reason to believe Amarin's stock is just getting started for the week, assuming the AdCom meeting scheduled for Thursday results in a positive outcome.
As today's briefing documents were benign in nature, it's not a reach to expect those on the AdCom panel will have similar thinking to those who compiled the briefing documentation.
As Biotech reporter Adam Feuerstein points out, the AdCom committee is comprised of 16 voting members, in which there are four endocrinologists and only three cardiologists.
There are only 3 cardiologists among the 16 voting members of $AMRN Vascepa FDA adcomm. There are 4 endocrinologists and 3 biostatisticians.— Adam Feuerstein (@adamfeuerstein) November 12, 2019
I find the paucity of cardiologists interesting, for reasons I want to ponder more.
A great biotech follow on Twitter, TerraPharma, highlighted the six temporary voting members for the meeting.
Six temporary voting members added to $AMRN adcom. 2 biostatisticians, 1 pharmacologist, 1 hematologist/coagulation specialist, 1 public health/research specialist, 1 consumer rep. pic.twitter.com/sHgr5bD14A— TerraPharma (@TerraPharma1) November 12, 2019
In order to get ready for expanded labeling, Amarin said last week that they are moving forward with their plans to double the sales force from 400 to 800 sales reps. Assuming Thursday's AdCom gets a positive vote, the FDA will have until December 28th to approval the new indication for Vascepa.
Amarin has also been on a PR blitz as the company released follow-up data from the REDUCE-IT trial which showed a higher CV risk reduction in a pre-specified subgroup.
Additionally, Amarin released results from another study which showed icosapent ethyl (Vascepa) in high CV risk patients provides exceptional CV event reduction as well as cost-savings in-trial and over patients’ lifetime.
The excitement for Amarin and it's investors doesn't slow down as results from the EVAPORATE trial are scheduled to be released before market opens on November 18 and will be presented the same day at AHA's Late Breaking Science Session.
The EVOPORATE trial is the first study which use MDCT to evaluate the effects of icosapent ethyl (Vascepa) on plaque characteristics in patients with persistent high triglyceride (TG) levels.
Additionally, a great video was just posted of REDUCE-IT's principal investigator, Deepak L. Bhatt, MD, MPH, discussing the trial and the benefits of Vascepa.
It will be an exciting 45 days for investors, Amarin employees and patients who will potentially benefit if Vascepa gets expanded labeling.