FDA Panel Backs Wider Use Of Pfizer HIV Drug Selzentry
08 Oktober 2009 - 9:17PM
Dow Jones News
A Food and Drug Administration panel Thursday backed the use of
Pfizer Inc.'s (PFE) HIV drug Selzentry as part of a first-line
treatment regimen for newly diagnosed patients.
Selzentry is currently approved for use to treat HIV in patients
who have failed other medications, but Pfizer is seeking FDA
approval to use the product in people who haven't been previously
treated with other drugs.
The FDA brought the issue to an outside panel of medical experts
who serve on the agency's antiviral drugs advisory committee for
review. The panel voted 10 to 4 in favor of a question that asked
if the safety, effectiveness and resistance data supported approval
Selzentry treatment-naive patients who have a specific type of HIV
infection.
Selzentry was first approved in August 2007. The drug works by
inhibiting a pathway that HIV uses to infect cells rather than
treating the virus itself. Selzentry blocks a receptor known as
CCR5 to prevent HIV infection. However, in some patients, HIV uses
another receptor known as CXCR4 to enter cells, meaning Selzentry
wouldn't work in those cases.
An FDA staff review of Selzentry said the drug "appeared to be
well-tolerated...with relatively few patients discontinuing for
adverse events." The agency also said no new safety signals were
found during a post-marketing review of the drug, although the
review noted there was a "relative increase" of resistance
developing to Selzentry compared with patients taking another HIV
drug efavirenz.
Over time, most HIV viruses mutate and stop responding to the
drugs. The Centers for Disease Control and Prevention estimates
that about 1.1 million Americans have HIV. HIV is the virus that
causes AIDS. Patients with HIV are typically treated with a
"cocktail" of two or three types of drugs.
-By Jennifer Corbett Dooren, Dow Jones Newswires; 202-862-9294;
jennifer.corbett@dowjones.com