FDA approves Lipitor for reducing heart attack risk
pharmafile | August 5, 2004 | News story | |Â Â Â
The FDA has approved Pfizer's cholesterol-lowering statin Lipitor for a new indication – the prevention of cardiovascular disease by reducing heart attack risk.
The FDA based its approval on Pfizer's ASCOT (Anglo-Scandinavian Cardiac Outcomes Trial) trial, which found that the lowest dose of Lipitor (10mg) reduced the relative risk of heart attack by 36%.
The drug's benefits were seen so early on that the trial was halted prematurely after just two years.
"No other lipid-lowering agent has shown an effect as dramatic as Lipitor in terms of reducing cardiovascular disease and in offering this significant health benefit as fast as Lipitor," said Dr Joseph Feczko, Pfizer's president of worldwide development. "Lipitor clearly is different in its early ability to reduce heart attacks among a very broad population of patients, regardless of cholesterol levels."
The approval is just one of several recent boosts for the world's leading cholesterol-lowering drug.
The company's CARDS (Collaborative Atorvastatin Diabetes Study) trial showed Lipitor cut the risk of stroke by half in diabetes patients, findings which could further extend the drug's licence.
In addition, the government's National Heart, Lung and Blood Institute (NHLBI) announced new guidelines for lowering cholesterol, recommending that doctors should aim to lower cholesterol levels in high risk patients to below 70 mg/dL rather than the current guidance of 100mg/dL.
The update was based, in part, on the ASCOT trial which showed the cardiovascular benefits of low cholesterol levels, and could potentially open up the market to seven million new patients, in addition to the 36 million existing ones.
"It's becoming increasingly clear that Lipitor provides cardiovascular benefits beyond simply lowering LDL cholesterol," Dr Feczko said. "Lowering LDL levels with statin therapy has been shown to reduce death and disability, but based on recent studies, we now know that Lipitor provides earlier and greater benefits than lowering LDL alone."
Lipitor continues to dominate the $30 billion market with Pfizer reporting second quarter revenues of $2.3 billion, up 17% on last year.
Competition, however, will heat up with the approval of Merck and Schering-Plough's new two-in-one cholesterol pill Vytorin (Zocor and Ezetrol/Zetia combined).
Further FDA approvals may be on the cards for Lipitor, however, with the drug showing cardiovascular benefits in two other trials which pitted it against another statin.
In the REVERSAL study, Lipitor halted the progression of atherosclerosis – hardening of the arteries – while the other statin only slowed progression; in the PROVE-IT study patients taking Lipitor had a significantly lower cardiovascular events rate.
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