FDA Revokes Approvals For Blockbuster Heart Medications From AbbVie Inc (NYSE:ABBV)

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Combination pills Advicor and Simcor and Niaspan (niacin) and Trilipix (fenofibric acid) from AbbVie Inc (NYSE:ABBV) will no longer be on the market after the revocation of their approvals by the Food Drug and Administration (FDA).  The cholesterol-fighting combos have been selling for two years but in defense of its decision, the agency stated that it has tangible evidence that the combination therapies are not beneficial.

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According to Dr. Steven Nissen of the Cleveland Clinic, neither niacin nor fenofibric acid derivatives to statins have any meaningful benefit and besides there are significant harms associated with these drugs at the expense of the expected benefits.

Nonetheless, despite the FDA’s actions, the drugs were doing well in the market.  In 2012 and slightly before the arrival of the generics, Trilipix alone brought in more than $1 billion. Well, after discussions with the agency, AbbVie has confirmed that the drugs are off the market. The four brands are off patent.

The entry of generics in the recent past has led to declined sales for AbbVie. In 2013 when Trilipix and Niaspan went off patent, the dyslipidemia franchise brought in $1 billion which was way above the $179 million collected last year. Clearly generics are a hot cake.

However, the FDA’s conclusion is that scientific evidence no longer supports the contention that a drug-induced reduction in triglyceride levels in patients already on statins has any impact on cardiovascular risks. That means benefits derived from niacin ER tablets and fenofibric acid DR capsules alongside the statins do not have any effects hence they do not outweigh the risks.

There has been a systematic and consistent evaluation of lipid-lowering drugs as described by Dr. Michael Blaha of Johns Hopkins who was answering a question as to why these drugs had been given indications.

Hopkins argues that the latest unfolding is a clear sign that improvements in the simple lipid profile are not enough to give certainty to any drug and for routine use of any drug. Clear evidence of benefit on clinical outcomes must be provided especially for lipid-lowering drugs.

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