The Food and Drug Administration (FDA ) is withdrawing its earlier approval related to co administration with a statin for Niacin extended release tablets and fenofibric acid delayed release capsules. The decision of the FDA comes in the face of these medicines being ineffective in the treatment of high cholesterol levels.
The FDA’s withdrawal of approval will affect niacin extended-release (Niaspan, AbbVie) and fenofibric acid (Trilipix, AbbVie), as well as AbbVie’s Advicor and Simcor, both combining niacin with a statin.
According to a notification, issued by the FDA , Docket No. FDA-2016-N-1127, ‘no incremental benefit of Niaspan co administered with simvastatin or lovastatin on cardiovascular morbidity and mortality has been observed.’ The notification further adds that ‘addition of Niaspan did not reduce cardiovascular morbidity or mortality among patients treated with simvastatin in large, randomized controlled trials.’
The FDA justifying its decision to withdraw approval on Fenofibric Acid DR capsules ,Trilipix ( introduced by it in 2008), indicates that the capsule, an adjunct to diet in combination with a statin, to reduce Triglyceride and increase HDL-Cholesterol in patients, with mixed dyslipidemia and CHD (coronary heart disease), has been found to be ineffective.
Based on collective evidence from several large cardiovascular outcome trials, the FDA notification says that it had been concluded that the totality of the scientific evidence no longer supported the conclusion that a drug-induced reduction in triglyceride levels and/or increase in HDL cholesterol levels in statin-treated patients, resulted in a reduction of risk of cardiovascular events, on administration of the drug.
Thereby , allowing the FDA to conclude that the benefits of niacin ER tablets and fenofibric acid DR capsules, for co administration with statins no longer outweighed the risks, and the approvals for this, in all necessity, be withdrawn.
A similar thought process has dictated the authorities pulling back their approval of Advicor (niacin extended-release/lovastatin) and Simcor (niacin extended-release/simvastatin). Abbvie voluntarily pulled off the drugs from marketing shelves at the end of 2015. .