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Monday, November 25, 2013 10:20:42 PM
I am writing you to inquire your thoughts on the recent FDA and AHA guidelines regarding statins. It seems with the position currently proposed, the FDA and AHA have decided that lipid control medicines no longer provide a benefit for cardiovascular disease. I am especially interested to see if you have seen the results of the Marine and Anchor trials submitted to the FDA for Amarin Corp.'s drug Vascepa, which is 4gm per day.
If you believe that EPA has a future, it would be nice if you would show support for EPA drugs by requesting the FDA to reconsider their current position with Amarin. The FDA held an ADCOM on October 16th of this year and directed and steered the panel into a negative vote by challenging the efficacy of EPA in reducing CVE's. Not long after, the FDA rescinded it's SPA agreement with Amarin for the Anchor Trial citing 3 studies, ((Accord-Lipid, Aim-High and HPS2-Thrive) which according to the FDA challenged the science of lipid control and positive CVE correlation. Amarin already has a multi-year study currently with 6000+ patients enrolled to demonstrate the efficacy of Vascepa on CVE's called the Reduce-It Trial and has spent 10's of millions of dollars on this study already. Because of the FDA's position and rescission of the Anchor SPA, Amarin has potentially lost revenue that would have helped fund the Reduce-It Trial to end.
This study is important to millions of people and needs to be finished. Cardiovascular disease, as I'm sure you are aware, is the number one killer in the U.S. today. Again, I am asking for your support. Please visit epadruginitiative.com for further information. Time is of the essence.
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