Abbott Labs (NYSE: ABT) came a tad short of hitting a home run at its Food and Drug Administration advisory committee meeting yesterday, but a solid triple for Trilipix isn't bad -- and quite appropriate given its name.
The cholesterol drug is already on the market, but the panel of outside experts was tasked with determining whether the drug needs additional tests, and/or whether the marketing approval for its use in combination with statins should be revoked.
A strikeout would be costly. Trilipix and its older cousin, TriCor, brought in $1.5 billion last year.
Trilipix and TriCor lower triglycerides and increase good cholesterol, while statins such as Pfizer's (NYSE: PFE) Lipitor or AstraZeneca's (NYSE: AZN) Crestor lower bad cholesterol. A clinical trial run by the government showed that Trilipix, in combination with Merck's (NYSE: MRK) statin Zocor, didn't reduce heart problems in diabetics. In women, the combination might have been worse.
But the panel of outside experts was fairly lenient, pointing out issues with the study. Nine of the 13 panel members said the drug should keep its approval to be used in combination with statins. In a separate vote, six panel members said the information from the study should be added to the label. Even if the FDA agrees with the slight minority, it shouldn't affect sales much
The only thing keeping Abbott from hitting a home run was a unanimous recommendation that the company run a study to specifically look at the effect of Trilipix and statins on heart issues.
But really, the fence was set at 550 feet for that one.
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