2 January 2014
Dr. Curtis Rosebraugh
Director
10903 New Hampshire Avenue
Silver Spring MD 20993-0002
Subject: FDA Review of SPA / sNDA 202057/S-005,
Vascepa (icosapent ethyl) Capsules
Dear Dr. Rosebraugh:
We all have seen the classic Christmas film, ‘It’s a Wonderful Life’ with Jimmy Stewart as George Bailey and the idyllic community of Bedford Falls. Its message is a powerful one… that each person’s life touches others. Most - especially those that have lost loved ones - have seen this valuable truth played out in their life. No doubt the FDA’s decision regarding the ANCHOR Special Protocol Assessment Agreement and the sNDA for Vascepa will impact lives for better or worse.
That said, in my opinion, Dr. Robert Smith, the Chairman, got it right in his ADCOM vote statement as did Dr. Frank Harrell, the Biostatistician from Vanderbilt.Why? In my opinion, they were looking at the big picture.
Dr. Smith: “I voted yes. My vote was based on my considered balance of efficacy and safety, recognizing that the data for neither of these is as adequate as I might wish it would be, which is usually the case in trying to make decisions like this… I was influenced strongly in my vote by what I consider to be favorable safety data. I fully accept that those data are not perhaps as extensive as one would like to have to be convinced that there are not safety issues. But compared to the safety profiles of most other drugs that I'm familiar with, it's a very highly safe intervention, from the data that we have. In terms of efficacy, I perceive there being quite substantial triglyceride lowering, irrespective of what the choice is for placebo group. And my main issues with the placebo group have had to do with other lipid endpoints. I accept and understand the data that are available from prior studies. But I feel that the dose differences in this study and the higher risk patient population or potential higher benefit patient population, based on triglyceride levels, at least, is being addressed in the REDUCE-IT study versus prior Omega-3 studies, for example; whereas I remain very uncertain about how outcomes will come out from the REDUCE-IT study, I feel uncertain rather than certain that this will not be effective. So putting all this together, I feel that approval of the drug now would expose patients to potential benefit that we have yet to learn more about at a very low risk of harm. And what we're looking at is the period of the next three to four years until the REDUCE-IT study is completed, perhaps a little more than that by the time it's analyzed and assembled. I chose not to make a vote based on concerns about how the FDA would deal with the issue if it turned out the REDUCE-IT study did not show outcome benefits in cardiovascular disease. But, rather, I voted on the situation as I've described it.”
Dr. Harrell:“I was willing to take a leap of faith about the safety profile and to narrow the scope to the lipid profile, and because I was .6 and there was no maybe.”
I have faith and trust in the integrity of the FDA and truly believe the agency will make the right decision regarding the ANCHOR Special Protocol Assessment Agreement and the sNDA, as no doubt the FDA must also focus on the big picture as it works to advance public health.
Respectfully Submitted,
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