Manufactured by Pfizer, the drug received a unanimous vote from 12 health advisers to sell under the brand name Celsentri. It would represent the first so-called CCR5 receptor antagonist to be sold.
If approved, maraviroc would be the first member of a new class of oral HIV medicines in more than a decade that 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.
Additional studies are underway to determine maraviroc's effectiveness in treatment-naive patients and also its interaction with other drugs and its effects on women and minorities.
According to earlier studies, 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.
However, the federal authorities are worried over 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.
Though no increase in lymphomas or infections was detected among patients given Celsentri, but there was a modest increase in liver problems. Also, the drug has no significant impact on the heart, and no increased incidence of liver problems, cancer or infection compared with treatment involving other HIV drugs.
