FDA to Pull Approval of 2 Drugs Used in Combo With Statins

The action, to be published Monday in the Federal Register, comes as the agency puts increased focus on long-term safety of drugs that treat diabetes and obesity, and prevent cardiovascular events.

On Monday, FDA will withdraw approvals for 2 medications that had been used with statins to treat high levels of cholesterol. The pending decision was listed in documents ready for publication in the Federal Register and was first reported by Medscape.

The affected therapies, both sold by AbbVie, are niacin extended release (Niaspan) and fenofibric acid (Tripilix). The order will also affect the combination therapies Advicor, which combines niacin with lovastatin, and Simcor, which combines niacin with simvastatin.

This unusual step is a result of FDA’s increased attention to long-term safety effects of medications for diabetes, obesity, and to prevent heart disease. Documentation with the notice lists results from several trials, including those from ACCORD, AIM-HIGH, and the HPS2-THRIVE Collaboration Group. The agency said the evidence "no longer supports the conclusion that a drug-induced reduction in triglyceride leels and/or increase in HDL-cholesterol levels in statin-treated patients results in a reduction in the risk of cardiovascular events."

FDA’s pending withdrawal notice states that that agency asked AbbVie to voluntarily stop marketing Advicor and Simcor and the company agreed, waiving its right for a hearing.

“The agency has also determined that Advicor and Simcor were withdrawn from sale for reasons of safety and effectiveness, and FDA will not accept or approve abbreviated drug applications that reference Advicor and Simcor,” the notice states.

Niacin extended-release (Niaspan) received approval in 1997. Advicor was subsequently approved to treat hypercholesterolemia, both familial and nonfamilial, as well as mixed dyslipidemia for patients whose triglycerides or low-density lipoprotein (LDL) cholesterol levels remain high on less-intense therapy.

Simcor was approved in 2008 to treat total cholesterol levels, apolipoprotein B, triglycerides or to raise HDL or “good” cholesterol in patients with hypercholesterolemia and mixed dyslipidemia.