Submission for Indication Studied in the ANCHOR Phase 3 Clinical Trial Under Special Protocol Assessment Agreement With FDA
BEDMINSTER, N.J. and DUBLIN, Ireland, June 19, 2013 (GLOBE NEWSWIRE) -- Amarin Corporation plc (Nasdaq:AMRN), a biopharmaceutical company focused on the commercialization and development of therapeutics to improve cardiovascular health, announced today that it was informed yesterday by the U.S. Food and Drug Administration (FDA) that the FDA will convene an advisory committee on October 16, 2013 in connection with the FDA's review of the Supplemental New Drug Application (sNDA) seeking approval for the use of Vascepa® (icosapent ethyl) capsules as an adjunct to diet in the treatment of adult patients with high triglycerides (TG ≥200 mg/dL and
Shortfish -an important note in this announcement IMHO are the comments by Dr Brinton ( President American Board of Clinical Lipidology ) " Currently many of the patients are recieving another prescription omega 3 which is not indicated for this indication . Having instead an omega 3 product which lowers LDL in addition to TG's and tolerability comparable to placebo , and is FDA approved for use on top of statin therapy would be a welcome addition"
Great to see more high profile " thought leaders " coming out in support of Vascepa
FDA advisory panel is a normal step for a drug for new indication.
FDA by itself does not have the resources to do proper due diligence.
As far as I know,advisory panel role is to identify:
1) Safety issues
2)Comparative look at this drug vs.other drugs already approved.Does it provide significant benefits?
3) Are the results from previous trials or studies legitimate and can they be duplicated in larger population?
Merck was asked to do larger study because there were concerns about side effects and safety.
Dr Brinton certainly set a supportive tone which I believe will carry into ADCOMM. the FDA seems to be covering all bases before the ground breaking decision to approve Vascepa over for this massive indication.
This is great news and 100% expected. It's one more anticipated hurdle that we are now fully aware of, and it will be knocked down, just like every other hurdle that has been placed in front of this drug before. We are absolutely moving forward, step by calculated step, and we're almost to the promised land with this extraordinary drug. As many of us have indicated in the last few weeks, NCE is becoming a moot point, and the approval of the Anchor indication is what will rocket propel the PPS. And if we get an 'oh, by-the-way' NCE approval along with it, even better yet.
Sentiment: Strong Buy
I agree it's good news. Honestly I was worried that the FDA was going into a decision without it. The more minds involved in the opinion the better because it minimizes the influence of individual bias. For this reason, I think AMRN wanted ADCOMM (and may have asked for this) as they mentioned preparations before the FDA announced it.