Almost exactly a year after Merck
Thanks for the vote of confidence, FDA, but I think the damage has already been done.
Year-over-year sales of the duo's cholesterol-fighting drugs, Zetia and Vytorin (the latter being a comination of Zetia and Zocor), fell by 15% in the third quarter of last year, as patients migrated to Pfizer's
In citing why Vytorin should still be used, the FDA points out that the drug still lowers "bad" LDL cholesterol more than Zocor does, and the surrogate marker is a good predictor of risk for cardiovascular disease.
That seems to be a change in stance from when the agency didn't accept LDL levels, instead forcing clinical trials to measure outcomes such as heart attacks for drugs such as Merck's MK-0524A and Isis Pharmaceuticals'
Ultimately, the level of sales of Vytorin and Zetia will be determined by the results of Improve-It, a trial that measures Vytorin's effect on cardiac events such as heart attacks. Unfortunately, the trial's results aren't due until 2012, so sales will likely be relatively stagnant until then, despite the FDAs green light for the drug.
Further pharmaceutical Foolishness:
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Fool contributor Brian Orelli, Ph.D., doesn't own shares of any company mentioned in this article. Pfizer is also an Inside Value pick. The Fool owns shares of Pfizer. Check out the Fool's disclosure policy.