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FDA Panel urged to OK Pfizer HIV drug
 
 
  From the Associated Press
April 25, 2007
 
WASHINGTON - The federal government should approve a novel drug that targets the cells of HIV-infected patients and not the virus itself, health advisors recommended Tuesday.
 
The 12 advisors unanimously voted to urge the Food and Drug Administration to approve maraviroc, which Pfizer Inc. hopes to sell under the brand name Celsentri.
 
It would represent the first so-called CCR5 receptor antagonist to be sold.
 
The drugs block a secondary but crucial doorway typically used by the human immunodeficiency virus to enter white blood cells, which are important in the immune system.
 
The FDA advisors recommended that Pfizer further study Celsentri's interaction with other drugs and its effects on women and minorities.
 
The group's advice is nonbinding, but the FDA generally follows it.
 
The FDA and Pfizer have cited studies showing that adding Celsentri to a traditional HIV treatment regimen was more effective in dropping the virus below detectable levels.
 
HIV is the virus that causes AIDS.
 
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 Celsentri, but said there was a modest increase in liver problems
 
 
 
 
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