FDA Approves New Cholesterol Drug
Warner-Lambert Co. said Wednesday that the Food and Drug Administration cleared the drug Lipitor, which has produced dramatic results in the treatment of high cholesterol, for sale in the United States.
Shares of Warner-Lambert and Pfizer Inc., which will co-market the drug in the United States, rose on the news. Warner-Lambert’s stock gained $2.125 to close at $76.375 and Pfizer added $1.75 to close at $82.375. Both trade on the New York Stock Exchange.
Lipitor “is clearly the most potent of this class of drugs,” said Hambrecht & Quist analyst Alex Zisson. “This could easily be a billion-dollar drug worldwide. In fact, it should be.”
The company said Lipitor is the only drug in its class specifically indicated for lowering both elevated LDL cholesterol and triglycerides in patients with high cholesterol.
It said that although 52 million American adults need treatment for high cholesterol, less than a third of those who could benefit from medication are now taking it.
In placebo-controlled, dose-response studies in patients with high cholesterol, Lipitor reduced elevated LDL cholesterol--the so-called bad cholesterol--by 40% to 60% across the dose range of 10 to 80 milligrams administered once daily, the company said.
In addition, Lipitor lowered triglycerides--fatty substances in the blood that are believed to contribute to coronary heart disease--by 20% to 40%.
Lipitor tablets are an HMG-CoA reductase inhibitor, or “statin.” Warner-Lambert said that in clinical trials, Lipitor was superior to other statins, including Merck & Co.’s Zocor and Mevacor and Bristol-Myers Squibb’s Pravachol at reducing elevated total cholesterol, LDL cholesterol and triglycerides.
“The ability of Lipitor to dramatically reduce both elevated LDL cholesterol and triglycerides enables the medical community to enter a new era of cholesterol management,” said Melvin Goodes, chairman and chief executive of Warner-Lambert.
The starting dose of Lipitor is 10 milligrams taken as a single daily dose at any time during the day, with or without food, the company said.
“The National Cholesterol Education Program has set guidelines for reducing cholesterol, yet many of those people receiving treatment are not reaching treatment goals,” said Donald Hunninghake, director of the Heart Disease Prevention Clinic at the University of Minnesota Hospital in Minneapolis.
