FDA withdraws approvals of niacin and fenofibric acid in combination with statins

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The FDA withdrew the approvals of statins in combination with Niaspan (niacin extended-release tablets) and Trilipix (fenofibric acid delayed-release capsules) on April 18.

AbbVie, which manufactures both medications,  requested that the FDA withdraw the approvals after the agency requested they voluntarily stop marketing the drugs for these indications. The withdrawals also affect seven abbreviated new drug applications for niacin extended-release tablets and three abbreviated new drug applications for fenofibric acid delayed-release capsules.

The FDA first approved niacin extended-release tablets for several indications on July 28, 1997. Before the drug’s removal, the labeling read that adding niacin extended-release tablets to simvastatin did not reduce cardiovascular morbidity or mortality among patients in a large, randomized, controlled trial.

The FDA first approved fenofibric acid delayed-release capsules on Dec. 15, 2008, for several indications. The labeling of the capsules indicated that they had no incremental benefit on cardiovascular morbidity or mortality compared with statin monotherapy.

The FDA mentioned the results of the following studies helped it come to the conclusion to withdraw the approvals: the ACCORD trial ( published in April 2010), the AIM-HIGH trial ( published in December 2011) and the HPS2-THRIVE trial ( published in July 2014).

“Based on the collective evidence from several large cardiovascular outcome trials, the Agency has concluded that the totality of the scientific evidence no longer supports the conclusion that a drug-induced reduction in triglyceride levels and/or increase in HDL-cholesterol levels in statin-treated patients results in a reduction in the risk of cardiovascular events,” the FDA wrote. “Consistent with this conclusion, FDA has determined that the benefits of niacin ER tablets and fenofibric acid DR capsules for coadministration with statins no longer outweigh the risks, and the approvals for this indication should be withdrawn.”