SILVER SPRING, MD — Citing a lack of cardiovascular benefit, the FDA is taking the unusual step of withdrawing approvals it had previously given for use of niacin and fenofibric acid with statins to treat high cholesterol[1].

The decision affects the indication of niacin extended-release (Niaspan, AbbVie) and fenofibric acid (Trilipix, AbbVie), as well as AbbVie's Advicor and Simcor, both of which combine niacin with a statin.

Niaspan was first approved for several indications by the FDA in 1997 and later indicated in combination with simvastatin or lovastatin for the treatment of primary hyperlipidemia and mixed dyslipidemia when monotherapy with any of the three drugs was inadequate.

Trilipix first gained FDA approval in 2008 for several indications and was indicated as an adjunct to diet in combination with a statin to reduce triglycerides and increase HDL cholesterol in patients with mixed dyslipidemia and CHD or a CHD risk equivalent.

Based on several large cardiovascular outcome trials including AIM-HIGH, ACCORD, and HPS2-THRIVE, the FDA decided that "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.

"Consistent with this conclusion, the FDA has determined that the benefits of niacin ER tablets and fenofibric-acid [delayed-release] capsules for coadministration with statins no longer outweigh the risks, and the approvals for this indication should be withdrawn," a document filed in the Federal Registry today states[1].

The same reasoning was cited for pulling its approval of Advicor (niacin extended-release/lovastatin) and Simcor (niacin extended-release/simvastatin)[2]. Both drugs were voluntary pulled from the shelves at the end of 2015 by Abbvie.