FDA Panel Backs Key Use of Abbott Cholesterol Drug
Mattthew Perrone, AP Health Writer
WASHINGTON (AP) – A Food and Drug Administration advisory panel recommended on May 19, 2011 that a blockbuster drug from Abbott Laboratories still be marketed for use with other widely used cholesterol-lowering drugs, despite a government study that questioned the benefit.
The panel also recommended a new study of Abbott’s Trilipix to see if it reduces heart attacks when combined with drugs like Lipitor and Zocor.
Trilipix is a fibrate, a drug that lowers blood fats called triglycerides while boosting “good cholesterol.” The drug is approved for combination use with statins, the most widely used class of drugs that reduce cholesterol levels.
But a 5,000-patient government study released in March showed that diabetic patients taking Trilipix plus a statin had just as many heart attacks as patients taking a statin alone.
The FDA asked its panel whether combination use of Trilipix should be revoked.
Nine out of 13 panelists voted that the drug’s label should keep the combination as an approved use. Six voted that the label should be updated with results from the government study. Three said the labeling does not need to be changed.
The FDA is not required to follow the advice of its panels, though it usually does.
Drugmaker Abbott has downplayed the results of the study by saying that two-thirds of the patients included would not have been eligible for the drug under prescribing guidelines.
The drug is indicated for patients with high triglycerides and low “good cholesterol,” known as high-density lipoprotein.
The FDA panel voted unanimously that Abbott be required to conduct a study in those patients to determine if the Trilipix-statin combination reduces heart attacks.
Wells Fargo analyst Larry Biegelsen said the study could cost Abbott $100 million to conduct and be a “modest negative,” if required by the FDA. He said a change in the drug’s label would have virtually no effect on the company’s results.
North Chicago-based Abbott reported combined sales of $1.6 billion last year for Trilipix and TriCor, an older drug that contains the same active ingredient. Sales of both drugs are expected to decline after 2012 when TriCor loses patent protection, exposing it to low-cost generic competition.
Trilipix is not the first blockbuster drug that has come under scrutiny after disappointing study results. In 2008, Merck’s blockbuster cholesterol pill Vytorin was criticized after a study showed it was no better than a low-cost generic at reducing plaque buildup in certain arteries.
The Associated Press.
Filed Under: Drug Discovery
