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FDA panel wants new Trilipix data

An advisory committee to the US FDA has voted to recommend the agency retain the current indication for Abbott's cholesterol drug Trilipix statin but also require Abbott to gather more clinical data to support additional use

An advisory committee to the US Food and Drug Administration (FDA) has voted in favour of recommending that the federal agency retain the current indication for Abbott's cholesterol drug Trilipix (fenofibric acid) for co-administration with a statin but also require Abbott to gather more clinical data to support statin/fibrate combination use.

The FDA's Endocrinologic and Metabolic Drugs Advisory Committee made its recommendations after reviewing the results of Abbott's ACCORD Lipid study as they relate to the use of Trilipix in combination with a statin in patients with mixed dyslipidaemia and at high risk of heart disease.

In 2008, Trilipix became the first fibrate to be specifically approved by the FDA for use in combination with a statin, although the two kinds of drugs had frequently been prescribed in combination off-label.

Under the FDA's approval, patients who take Trilipix with a statin must either have coronary heart disease or a coronary heart disease risk equivalent and must be on optimal statin therapy to achieve their LDL cholesterol goal.

"Abbott appreciates the Committee's recognition that the totality of data, including ACCORD Lipid, supports retaining the co-administration indication for Trilipix in appropriate patients," Eugene Sun, vice president, Global Pharmaceutical Clinical Development, said in a statement.

"We also appreciate the request for more clinical data and look forward to further discussions with the FDA."

The FDA is not required to follow the committee's advice, but will take it into account during its decision-making process on Trilipix.

In June 2009, Abbott and AstraZeneca, which co-promote Trilipix in the US, filed a new drug application with the FDA for Certriad, a combination product containing Trilipix and AstraZeneca's blockbuster statin Crestor (rosuvastatin), for the treatment of mixed dyslipidaemia.

In late 2010, however, the companies said they were giving up on the combination product after receiving a complete response letter from the FDA earlier that year declining to approve the application and asking the companies for additional information.

24th May 2011

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