In October, the FDA told Abbott that it needed more time to review the drug, the follow-up to TriCor. TriCor generated $886 million of sales in the first nine months of 2008.
Trilipix was approved for use along with diet to help lower triglycerides and LDL cholesterol and to boost HDL cholesterol in patients with lipid problems. In certain patients, guidelines recommend a combination with a statin to further improve lipid levels.
"Only 35% of patients with lipid problems are currently being treated with lipid therapies, and many are not reaching treatment targets for all three key lipids," said Michael Davidson, a clinical professor at the University of Chicago's Pritzker School of Medicine. "The approval of Trilipix is good news for patients because now there is a new treatment option that can be used alone or in combination with a statin to help address lipid problems."
The drug will also be submitted in 2009 for approval as part of a fixed-dose combination with AstraZeneca PLC's (AZN) Crestor.
In after-hours trading, Abbott share were trading down 0.2% at $51.54.
-By Jay Miller, Dow Jones Newswires; 201-938-2331; jay.miller@dowjones.com
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Publié le 15 Décembre 2008 Copyright © 2008 Dowjones





