Amarin Corp Plc (AMRN)

[DeepBreath]

Article from Robert Weisman
FDA Lobbying

Of course I sent him an email:
Mr. Weisman,

I appreciate your story "Patients's advocates press FDA to retain lifesaving drugs", and would like to tell you about another company and drug that is going through similar problems with the FDA.

Amarin Corporation plc is a biopharmaceutical company focused on the commercialization and development of therapeutics to improve cardiovascular health. Amarin's product development program leverages its extensive experience in lipid science and the potential therapeutic benefits of polyunsaturated fatty acids. Vascepa® (icosapent ethyl) is Amarin's first FDA approved product and is available in the United States by prescription. Vascepa is the first and only pure EPA omega-3 fatty acid that has been clinical proven to significantly reduce TG levels without increasing LDL-C levels and provide a spectrum of additional lipid treatment benefits with a tolerability and safety profile similar to placebo.


Beginning this year, Amarin began selling Vascepa in the Marine Indication (trigs >500 mg/dl) and submitted an sNDA to expand the label to the Anchor Indication (trigs 200-500 mg/dl). In both studies, Vascepa proved its efficacy in lowering Trigs, Cholesterol and Inflammation Markers while maintaining a safety profile compared to a placebo. The FDA ordered an ADCOM for Oct 16th. At this meeting it was clear what the intention of the FDA was and how it stacked and steered the Panel to a negative vote. The FDA questioned whether or not this drug would reduce Cardio-Vascular events even though it was never the intention of the sponsor. Amarin and the FDA were already involved in the Reduce-It study that would determine outcomes. Just as important, the FDA used the results of three different studies (Accord-Lipid, Aim-High and HPS2-Thrive), using different compound (fibrates and niacin) with a different patient subgroup (trigs <200 mg/dl) to rescind the SPA agreement it had with Amarin. These studies were well known by the FDA prior to the ADCOM and were never mentioned in the sNDA letter or at any point prior to the ADCOM.


Interestingly enough, earlier this year a Citizens Petition (Lovaza Citizen Petition, Feb 2013) was filed by John Fuson and Crowell and Moring LLP. This petition it seems, was nothing more than an attempt to delay the New Chemical Entity decision by the FDA for Amarin's drug Vascepa. The petition's main goal was to have Vascepa's API listed into the OB retroactively by GSK drug Lovaza. In August, the FDA failed to rule on the petition, ignoring it's own rules, therefore resulting in a further delay in the NCE decision. John Fuson also happens to be a former employee of the FDA and has represented GlaxoSmithKline in an antitrust case in 2005. Keep in mind the Citizens Petition has delayed the NCE decision for Amarin's Vascepa benefitting it's competitor GSK's Lovaza.


Vascepa, with the safety profile of a placebo is needed in the mixed dyslipidemia group, especially for diabetics such as my mother. The FDA is refusing to balance the risk/reward with the use of this drug to the outrage of many patients and clinicians. Recently a group at http://www.epadruginitiative.com/ has released more information regarding this topic. Getting this corrupt story out into public view would be a great service to the patients and doctors who support this drug. For this, I ask your help.