* Abbott’s TriLipix approved for stand-alone and combo use
* To seek approval in 2009 for TriLipix/Crestor combo pill
* Abbott shares unchanged in after-hours trading (Adds details on drug, plans for TriLipix/Crestor pill)
By Ransdell Pierson
NEW YORK, Dec 15 (Reuters) - U.S. regulators have approved TriLipix, a successor to Abbott Laboratories Inc’s (ABT.N) blockbuster TriCor medicine used to lower heart-damaging blood fats called triglycerides, the drugmaker said on Monday.
Abbott also said it plans to seek U.S. approval in 2009 for a fixed-dose combination pill that pairs TriLipix with Crestor, a potent member of the “statin” family of cholesterol fighters that is sold by AstraZeneca Plc (AZN.L).
Abbott had been expecting approval this year of TriLipix, a derivative of $1.2 billion-a-year TriCor, well before the parent drug begins facing generic competition in 2011. Both medicines, which belong to the fibrate class of treatments, also cut levels of “bad” LDL cholesterol and somewhat raise levels of heart-protective “good” HDL cholesterol.
Investors are hoping that TriLipix will wrest away many current TriCor patients and deter current and future patients from opting for cheaper TriCor copycats once they hit the marketplace.
Unlike TriCor, TriLipix was approved not only for use by itself, but also in combination with statins — the widely used class of LDL-lowering drugs that also include Pfizer Inc’s (PFE.N) Lipitor and generic forms of Merck & Co’s (MRK.N) Zocor, sold under the chemical name simvastatin.
Statins excel at reducing LDL cholesterol and can raise HDL levels by as much as 10 percent. But they have no major effect on triglycerides, a reason that TriCor is widely prescribed.
TriLipix used in trials alongside statins helped improve levels of triglycerides, LDL and HDL better than the respective therapies alone. But TriLipix has not been shown to prevent heart disease or heart attack.
Although TriCor is not approved for use with statins, many doctors have long prescribed it that way because they are free to match approved medicines in any way they wish.
But Abbott has not been allowed to market TriCor for such combination use because it is not formally sanctioned, a restraint that will not apply to TriLipix.
Although the FDA in October said it needed more time to review TriLipix, Abbott accurately predicted the agency would grant the medicine its blessing in the current quarter.
Shares of Abbott were unchanged in extended trading, having closed up 1.8 percent to $51.64 in regular trading on Monday. (Reporting by Ransdell Pierson; Editing by Tim Dobbyn)