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cure for the common cold remains as elusive as ever. A federal advisory
committee recommended yesterday that the first drug aimed at treating the
cause of the cold rather than just its symptoms not be approved.
In a unanimous decision, the Food and Drug Administration's advisory
panel on antiviral drugs said there were too many questions about the safety
of the drug, which is made by ViroPharma (news/quote)
of Exton, Pa., to allow its widespread use merely to shorten the duration of
an ailment that is not life-threatening and goes away by itself.
"It's a mild, self-limited illness, and it's very common," Dr. Roy M.
Gulick, associate professor at Weill Medical College of Cornell University
and chairman of the panel, said in an interview. "Literally, millions of
people could be taking the drug." For such a drug, he said, the safety
aspects must "be very well known and clean."
The F.D.A. usually follows the recommendations of its advisory panels,
which are made up of outside experts.
The decision is a blow to ViroPharma and to Aventis (news/quote),
the European pharmaceutical giant that would market the drug in the United
States and Canada. ViroPharma has no other drugs on the market or in
advanced clinical trials.
Martin J. Driscoll, head of commercial operations at ViroPharma, said
yesterday, "We remain optimistic that we can do the necessary work to
address the concerns expressed by the committee today and ultimately gain
approval for the product."
The drug, known as Picovir, has attracted attention because it directly
attacks a family of viruses, known as picornaviruses, that cause half or
more of the billion colds caught in the United States each year. The drug
lodges in a pocket in the virus's coat, interfering with the germ's ability
to infect cells and make copies of itself. Other cold remedies only suppress
symptoms, like runny noses or coughs.
In clinical trials, Picovir shortened the length of the cold to roughly
six days from seven. Patients took the pills three times a day for five
days. But the first treatment has to start within 24 hours of the onset of
symptoms, which some panel members said might be difficult with a drug sold
by prescription.
While the F.D.A.'s own staff reviewers said the results of the clinical
trials were "variable," the advisory panel members reached a consensus that
the drug worked, Dr. Gulick said. The major concern, he said, was that
Picovir appeared to lower the effectiveness of oral contraceptives. And some
women taking both Picovir and birth control pills experienced bleeding
between menstrual periods.
The panel also questioned whether the drug could be used by the general
population because the participants in the clinical trial were mainly young,
white, otherwise healthy women. "It was in women and nonsmokers that it had
the best benefit," said Dr. Princy N. Kumar, chief of the division of
infectious diseases at Georgetown University Medical Center and a panel
member.
Another concern was that the virus seemed to mutate to develop resistance
to the drug.
ViroPharma's stock did not trade yesterday because of the panel meeting.
It closed on Monday at $13.41 after dropping 18 percent last week because of
analysts' predictions that the drug would be rejected.
Aventis paid $25 million for the North American marketing rights for
Picovir, but ViroPharma may have to refund as much as $20 million of that if
certain milestones are not met. The details of those have not been
disclosed.