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FDA Panel To Vote On Continued Marketing Of Abbott's TrilipixMay 18, 2011
By Jennifer Corbett Dooren, Of DOW JONES NEWSWIRES
WASHINGTON -(Dow Jones)- A U.S. Food and Drug Administration panel will vote Thursday on whether it thinks Abbott Laboratories' (ABT) cholesterol-drug Trilipix should continue to be marketed after a clinical study involving a similar drug raised safety and effectiveness questions.
Specifically, FDA's endocrinologic and metabolic drugs advisory panel will be asked to discuss the findings of a government study known as "Accord" that looked at whether certain drugs lowered the risk of heart attacks and strokes in people with type 2 diabetes.
One part of the study compared patients taking the cholesterol-lowering drug simvastatin to those taking simvastatin and Abbott's TriCor, which is considered a fibrate. Trilipix, approved by the FDA in 2008, is similar to TriCor, which was used in the government-funded study. Overall, that part of that study--which was released last year--found no difference in the cardiovascular outcomes between the two patient groups. Trilipix and TriCor had $1.58 billion in sales in 2010.
The FDA also noted that a subgroup analysis showed an increase of major cardiovascular events among women treated with TriCor and simvastatin compared to women treated with simvastatin and a placebo.