On November 2, 2011, Merck with seek approval from FDA, based on the small SHARP study, for a new indication -- on its Vytorin® combo-pill.
Friend of the blog, Marilyn Mann makes a succinct and cogent case against the approval. Do go read it all (longer version here), but here is a bit:
. . . .[B]ecause SHARP compared the combination of simvastatin and ezetimibe with placebo — there was no simvastatin arm — we have no way of knowing if ezetimibe contributed anything to the result. The FDA requires that combination drugs have additive effects over either drug alone. Merck has not shown that ezetimibe contributed anything to the effect in SHARP, so the new indication should not be approved. . . .
Stay tuned -- for the FDA Advisory Committee meeting -- I know we will.
1 comment:
Up until a few years ago it was a legal requirement for approval of combination drug products that you had to show that each product contributed to the effect. This requirement is no longer in the CFR (this occurred during the last administration). I don't know how or why it was removed but it may have something to do with FDA's push that began under the last adminstration and that is continuing to be more industry friendly and assist with drug development and approvals.
Salmon
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