FDA pulls approvals on AbbVie's ex-blockbuster heart meds

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Years after two AbbVie cholesterol-fighting combos were approved, the FDA has decided they shouldn’t be on the market. The agency pulled approvals on combination pills Advicor and Simcor altogether, and revoked approvals for Niaspan (niacin) and Trilipix (fenofibric acid) alongside standard statin therapy.

The agency said its decisions stemmed from "collective evidence from several large cardiovascular outcome trials." The combination therapies delivered no CV benefits in those trials, the FDA said.

"There is no evidence for any meaningful benefit for addition of niacin or fibric acid derivatives to statins,” Dr. Steven Nissen of the Cleveland Clinic told CardioBrief. “There are also significant harms associated with these drugs. In the absence of benefits, there remain only harms.”

AbbVie had already taken Advicor and Simcor off the market after discussions with the agency, the company said. The two drugs combined niacin with two different statins, lovastatin in Advicor and simvastatin in Simcor.

All four of the brands are off patent, and with generics in the mix, AbbVie’s lipid drug sales had already taken a big plunge. The dyslipidemia franchise brought in just $179 million last year, down from more than $1 billion in 2013, when Trilipix and Niaspan went off patent.

The AbbVie drugs were quite successful in their time, bringing in billions for the company, which was then part of Abbott Laboratories. Trilipix alone brought in more than $1 billion in 2012, the last full year before generics arrived.

In a Federal Register notice, the FDA said it has concluded that “scientific evidence no longer supports the conclusion that a drug-induced reduction in triglyceride levels and/or increase in HDL cholesterol levels” in patients already on statins actually reduces cardiovascular risks.

As such, “the benefits of niacin ER tablets and fenofibric acid DR capsules for coadministration with statins no longer outweigh the risks.”

One expert posed this question to CardioBrief: "We might ask, why were the indications for these drugs granted in the first place?” said Dr. Michael Blaha of Johns Hopkins. “This shows how far we have come in the evaluation of lipid-lowering drugs. It is now firmly established that improvements in the simple lipid profile are not enough, and that clear evidence of benefit on clinical outcomes is needed for routine use of lipid-lowering drugs as add-on to statin therapy."

- see the Federal Register notices here and here
- get more from CardioBrief

Special Report: The top 10 drug patent losses of 2014 - Trilipix, AbbVie

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