Tuesday March 19, 3:27 pm Eastern Time
Common cold drug cuts illness short, maker says
(UPDATE: Updates throughout with panel vote)
By Lisa Richwine
GAITHERSBURG, Md., March 19 (Reuters) - A drug that treats the common cold by attacking its cause, rather than just symptoms, suffered a setback Tuesday as U.S. advisers unanimously said regulators should not approve the medicine.
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Picovir, a pill made by ViroPharma Inc (NasdaqNM:VPHM - news) and co-developed with Aventis SA (NYSE:AVE - news), is the first medicine to strike viruses responsible for more than half of the 1 billion colds that afflict Americans each year. Over-the-counter remedies only mask symptoms such as coughing and a runny nose.
A U.S. Food and Drug Administration (FDA) advisory committee urged the agency to reject ViroPharma's application to sell the drug in the United States. The FDA usually follows its panels' advice.
Panel members said Picovir produced a modest benefit in some patients. In clinical trials, patients' colds cleared up about a day faster on average than with a placebo.
Members said they were not convinced, however, that the drug was safe enough to treat an illness that is not life threatening and goes away on its own.
``I have not seen adequate (data) from my point of view to conclude this drug is safe as we anticipate it will be used,'' said Dr. Brian Wong, a panel member.
FDA staff raised various safety concerns, including the possibility that Picovir may reduce effectiveness of oral contraceptives. Two women treated with Picovir for six weeks in a study testing whether the drug may prevent colds became pregnant while using birth control pills.
Panel members also worried that the drug may stimulate development of resistant cold germs.
Patients need to start taking Picovir within 24 hours after symptoms start. Treatment lasts five days, and the drug must be taken with food three times a day. If approved, Picovir would be available by prescription only.
Picovir targets picornaviruses, the viruses that cause more than half of all colds, and up to 80 percent in the peak spring and fall seasons.
Picovir works by sliding into a pocket on the surface of picornaviruses. By occupying the pocket, Picovir prevents the virus from copying itself and infecting healthy cells.
``The development of the first antiviral drug to treat the predominant cause of the common cold is a landmark development in the history of anti-infectives,'' Dr. Ellen Cooper, a ViroPharma vice president, told the FDA panel.
ViroPharma is based in Exton, Pennsylvania. |
