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FDA Approves Norvasc and Lipitor Combination |
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February 17, 2004
By Robert Fay
Pharmaceutical manufacturer Pfizer received approval from the U.S. Food and Drug Administration (FDA) on January 30 to market Caduet, a combination of the hypertension drug amlodipine besylate (Norvasc) and the cholesterol-lowering agent atorvastatin calcium (Lipitor) in a single tablet. Although other combination drugs have received FDA approval in the past, Caduet will be the first single drug to treat two conditions simultaneously. Pfizer anticipates making Caduet available in several months.
Norvasc is in a class of medications known as calcium channel blockers, which help lower blood pressure by causing blood vessels to relax and dilate. Lipitor is in a medication class called statins, which lower cholesterol by blocking the ability of the liver to manufacture cholesterol. Hypertension and abnormal amounts of cholesterol—too little HDL (“good”) cholesterol or too much LDL (“bad”) cholesterol—are risk factors for developing coronary heart disease, which is the leading cause of death worldwide. Sixty percent of cardiac events, such as heart attacks, occur in people who have both hypertension and high cholesterol. Yet by some estimates, less than 10 percent of people with these conditions have reached their blood pressure and cholesterol goals.
The practice of developing such combination drugs, which represents an emerging trend among pharmaceutical companies, has sparked a debate. Proponents of combination drugs say they benefit patients by allowing them to more easily adhere to their treatment regimen, which will increase the likelihood that they control their disease or condition. In addition, they point to the potential cost savings for patients because Caduet will require only a single copayment.
Critics of the practice claim that pharmaceutical companies are only seeking to protect market share and avoid patent expiration. Patents allow pharmaceutical firms to sell drugs exclusively, without competition from generic versions. Pfizer has sold Norvasc and Lipitor separately for several years. Norvasc’s patent was set to expire in 2007 and Lipitor’s in 2010. Combining these drugs into the drug Caduet renews the patents, protecting a huge revenue source until 2018. In 2003, worldwide sales of Norvasc and Lipitor were $4.23 billion and $9.23 billion, respectively.
The Cardiology Domain covers statins and calcium channel blockers in the treatment articles entitled Antihypertensive Therapy and Lipid Therapy. The Content Team will continue to monitor news about the development of medications.
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