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
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
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
Selzentry's product label includes a boxed warning about liver toxicity
(hepatoxicity) and a statement in the "Warnings/Precautions" section
about the possibility of heart attacks.
Pfizer states that Selzentry should be used with caution in patients at
increased risk for cardiovascular problems and that patients with signs or
symptoms of hepatitis (a liver disease) or allergic reaction after using
Selzentry should be evaluated immediately.
The FDA recommends that HIV-positive women should not breastfeed, whether or
not they are on antiretroviral medications.
The most common adverse events reported with Selzentry were cough, fever,
upper respiratory tract infections, rash, musculoskeletal symptoms, abdominal
pain, and dizziness, according to the FDA.
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