Tools:Print|E-mail Us|Most Popular
U.S. panel urges approval of new HIV drug
www.chinaview.cn 2007-04-25 08:50:14
  Adjust font size:

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.

Headquarters of Pfizer Inc.(File Photo)

    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)

Editor: Jiang Yuxia
Tools:Print|E-mail Us|Most Popular
Related Stories
UNESCO fights HIV/AIDS in southern Africa's education sector
12,000 people estimated to be infected with HIV/AIDS in Beijing
HIV program to enlist help of gay community
Home Health
  Back to Top