FDA Approves Abbott's Trilipix

December 16, 2008

December 16, 2008 (Bethesda, Maryland) — The Food and Drug Administration has approved TriLipix, a newer formulation of fenofibric acid made by Abbott Laboratories [1].

The agency approved the delayed-release medication for use along with diet to help lower triglycerides and LDL cholesterol and to raise HDL cholesterol. It is also the first fibrate approved for use in combination with a statin.

The approval is good news for Abbott. The active component in TriLipix is the same as in TriCor, an older formulation of fenofibric acid made by the company. TriCor is currently a massive moneymaker, breaking the $1 billion mark in sales in 2007, but will lose patent protection in 2011. In the first nine months of 2008, TriCor's worldwide sales were again nearing the $1 billion mark.

TriCor is not approved for use with statin therapy, however, even though clinicians frequently prescribe it with the cholesterol-lowering medications. Abbott and AstraZeneca are expected to submit an application to the FDA for a combination tablet that includes TriLipix and rosuvastatin (Crestor) in 2009.

Abbott recently settled a lawsuit that alleged the company violated antitrust laws in its attempt to prevent other companies from selling a generic version of TriCor. Abbott was accused of product switching, a strategy that involves retiring an existing drug and replacing it with a "new and improved version" so that pharmacists could not substitute the patented medication with a generic when prescriptions were filled. Abbott denied any wrongdoing.

According to financial analysts, the approval of TriLipix will allow Abbott to begin shifting patients to TriLipix from TriCor prior to facing generic competition.

  1. Abbott Laboratories. Abbott receives FDA approval for TRILIPIX (fenofibric acid), first and only fibrate indicated for use in combination with a statin for cholesterol management [press release]. December 15, 2008. Available at: http://www.abbott.com/global/url/pressRelease/en_US/60.5:5/Press_Release_0660.htm

 

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