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Headquarters of Pfizer Inc.(File Photo)
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BEIJING, April 25 (Xinhuanet) -- A U.S. Food and Drug
Administration advisory panel of 12 members unanimously recommended the approval
of a new type of drug by Pfizer Inc. to treat HIV infection, according to media
reports Wednesday.
The drug, currently known by its generic name
maraviroc, would be the first drug to inhibit a pathway that HIV uses to infect
cells rather than treating the virus itself. Maraviroc blocks a receptor known
as CCR5 in order to prevent HIV infection. Older Aids medicines attack the virus
itself. Pfizer would sell the drug under the brand name Celsentri.
Maraviroc may benefit some patients who are running
out of alternatives, panel members said.
"The drug is needed by a certain portion of the
population, and I think the benefits and risks clearly support its approval as
soon as possible," said Peter Havens, a panel member and a professor of
pediatrics at the Medical College.
"This is a new class of drug," added Dr. Jeffrey
Laurence, director of the Laboratory for AIDS Virus Research at Weill Medical
College of Cornell University, in New York City. "It attacks part of the way HIV
binds to a cell," he explained. "It looks spectacular in phase II and phase III
testing, in terms of lowering virus loads and increasing CD4 T-cell counts."
Viral load is the amount of the virus present in the
blood, and CD4 T-cells are both an important component of the body's immune
system and prime targets for HIV.
The FDA and Pfizer have cited studies showing that
adding maraviroc to a traditional HIV treatment regimen was more effective in
dropping the virus below detectable levels.
FDA concerns about the entire class of drugs include
the possibility of greater risk of infection, lymphoma or liver damage in HIV
patients. The drugs also have been linked to heart rhythm changes in laboratory
animals.
FDA reviewers noted no increase in lymphomas or
infections among patients given Maraviroc, but said there was a modest increase
in liver problems.
Pfizer said its analyses of studies of the drug found
no significant impact on the heart, and no increased incidence of liver
problems, cancer or infection compared with treatment involving other HIV drugs.
"Development of new classes of HIV drugs is
critically important," Laurence said. "We are getting more and more spread of
resistant virus as people get tired of the drugs they are on or tired of the
side effects of the drugs they are on. In addition, adherence to drug regimens
is a problem. Because of that, we are always looking for new agents."
Laurence noted that many people with HIV now view it
as a chronic disease. "But it can only be a chronic disease if we can keep up
with resistant strains of the disease," he said. "Maraviroc is another tool we
can use."
(Agencies)