FDA panel backs key use of Abbott cholesterol drug
A Food and Drug Administration advisory panel says a blockbuster drug from Abbott Laboratories should continue to be marketed for use with other cholesterol drugs, despite a government study that questioned the benefit.
Abbott's Trilipix is a fibrate, a drug that lowers blood fats called triglycerides. The drug is approved for combination use with statins, the most widely-used class of drugs that reduce cholesterol levels.
A government study released in March showed that diabetic patients taking Trilipix plus a statin had as many heart attacks as patients taking a statin alone. The FDA asked its panel whether combination use should be revoked.
Nine out of 13 panelists voted that the indication should remain on the label. Six voted that the label should be updated with results from the government study.