An advisory panel voted unanimously against recommending FDA approval for the first antiviral cold medication, dashing company hopes of having the
An advisory panel voted unanimously against recommending FDA approval for the first antiviral cold medication, dashing company hopes of having the drug on the market in time for this year's cold season. The FDA's Antiviral Drugs Advisory Committee cited safety concerns of the drug pleconaril, which it said were not balanced by the drug's "modest" benefits in treating an illness that is not life-threatening.
Pleconaril prevents the infection of cells by a group of germs called picornaviruses, which are the most common cause of the common cold. In clinical studies, the drug eased symptoms and cut the duration of colds by about a day. One concern is that pleconaril tablets must be taken within 24 hours of the first symptoms, making the drug's real-life usefulness questionable. Because colds are not serious illnesses, it's unlikely that patients would see a doctor within a day of the first symptoms.The drug's developer, ViroPharma and marketing partner Aventis Pharmaceuticals, had hoped to have it on the market in the earliest possible under the brand name Picovir. Mark McKinlay, vice president of research and development for Viro Pharma, says the drug isn't dead. The company plans to meet with the FDA in coming weeks to see what steps they need to take to get approval.
