FDA OKs New HIV Drug Selzentry
Selzentry Is First in a New Class of HIV Drugs Made to Slow HIV's Advance, Says FDA
Aug. 7, 2007 -- The FDA has approved Selzentry (maraviroc), an antiretroviral drug for use in adult HIV patients.
Selzentry is the first in a new class of drugs designed to slow the advancement of HIV, according to the FDA. HIV is the virus that causes AIDS.
Selzentry is an antiretroviral drug. After a fast-track review, the FDA approved Selzentry for use in combination with other antiretroviral drugs for the treatment of certain adults with HIV.
Specifically, Selzentry is approved for use in combination with other antiretroviral drugs for the treatment of adults with CCR5-tropic HIV-1 (also known as the "R5 virus") who have evidence of elevated levels of HIV in their blood despite treatment with other HIV medications.
Not all HIV patients have the R5 form of the HIV virus. A blood test shows whether or not a patient has that form of HIV.
Selzentry is expected to be available in the U.S. by the middle of September, states Pfizer, the drug company that makes Selzentry, in a news release.
How Selzentry Works
Rather than fighting HIV inside white blood cells, Selzentry prevents the virus from entering uninfected cells by blocking the predominant route of entry, the CCR5 co-receptor.
CCR5 is a protein on the surface of some types of immune cells. Among patients who have previously received HIV medications, approximately 50% to 60% have circulating CCR5-tropic HIV-1.
“This is an important new product for many HIV-infected patients who have not responded to other treatments and have few options,” the FDA's Steven Galson, MD, MPH, states in an FDA news release.
Galson directs the FDA’s Center for Drug Evaluation and Research.
The FDA granted Selzentry a priority review and approved Selzentry based on two studies that included 1,076 patients who showed evidence of HIV-1 in their blood, despite treatment with other HIV medications.
The patients' blood was tested for CCR5-tropic-HIV-1 to identify patients who were candidates for treatment with Selzentry. The FDA's approval was based on six months of data, according to Pfizer.
The FDA notes that Selzentry's safety and effectiveness have not been established in adult and pediatric patients who have never been treated with any other HIV drug, and Selzentry has not been tested or studied in pregnant women.