By Jared A. Favole and Jennifer Corbett Dooren Of DOW JONES NEWSWIRES WASHINGTON -(Dow Jones)- Federal regulators on Thursday said a completed review of a trial involving the popular and controversial cholesterol drug Vytorin doesn't change the agency's position that low cholesterol levels are beneficial to patients.
The Food and Drug Administration issued an update Thursday about an ongoing safety review with Vytorin, saying the combination drug is more effective at lowering cholesterol levels than another medicine alone.
Vytorin is a single-tablet combination of the drugs simvastatin and Zetia, which work by different mechanisms to lower bad cholesterol. A joint venture of Merck & Co. (MRK) and Schering-Plough Corp. (SGP) markets both Vytorin and Zetia. Simvastatin is sold by Merck under the brand Zocor, but has been available from several generic manufacturers after losing U.S. patent protection in 2006. The FDA's review showed Vytorin decreased cholesterol levels by 56%, while simvastatin alone decreased those levels by 39%.
The FDA has been reviewing Vytorin since the results of a study known as Enhance showed that Vytorin was no better than a less-expensive generic drug, simvastatin, at slowing artery-clogging despite reducing bad cholesterol to a greater degree.
The FDA said in a statement Thursday that based on currently available data, patients shouldn't stop taking Vytorin or other cholesterol-lowering drugs and should talk to their doctor or other health-care professional if they have any questions about Vytorin.
The agency said the study also showed neither drug affected the size of patients' artery walls even though they cut LDL, or so-called 'bad' cholesterol, levels after two years on treatment. It was expected that Vytorin would have shown a small reduction in the thickness of artery walls because it lowered LDL cholesterol levels almost 30% more than levels were cut among patients on Zocor alone.
Barclays Capital analyst Tony Butler said the FDA's findings could bring "some greater stability" to demand for both Vytorin and Zetia, by providing reassurance to doctors and patients. He sees Vytorin sales falling 11% in 2009 to $1.3 billion, and Zetia down 14% at $1.2 billion.
After the preliminary results from the Enhance study were released last January, the FDA said it would wait for the final results before considering whether any regulatory action was warranted. On Wednesday, the FDA suggested it wasn't going to take any action and was waiting for results from an 18,000-patient trial that will be completed in 2012. "IMPROVE-It will provide additional data regarding Vytorin's effect on the risk for cardiovascular disease," the agency said in a statement posted on its Web site Wednesday.
The Enhance study results raised questions about the FDA approval process for drugs aimed at lowering cholesterol or lipid-lowering drugs. The FDA looks at whether the drugs lowered LDL cholesterol for approval. Other studies have shown that lowering LDL reduces the risk of a person having heart attacks and strokes. However, an actual reduction in cardiovascular events isn't required for approval.
The FDA is still reviewing a study, called Seas, that found an increased risk of cancer and deaths from cancer in patients taking Vytorin, compared with those given a placebo. The study, released in July, shocked investors and the medical community.
-By Jared A. Favole, Dow Jones Newswires; 202.862.9207; jared.favole@dowjones.com
(Peter Loftus contributed to this report.)
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Publié le 08 janvier 2009 Copyright © 2009 Dowjones