UPDATE: FDA Panel Backs Wider Use Of Pfizer HIV Drug Selzentry
October 08 2009 - 3:59PM
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
of 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.
James Neaton, a biostatistics professor at the University of
Minnesota, voted against earlier use of Selzentry over concerns
that the drug didn't appear to be more effective than efavirenz at
suppressing a patient's viral load or detectable HIV levels. Other
panel members were concerned patients could develop resistance to
that drug or other drugs sooner if used in a first-line
setting.
The panel members who supported earlier use of Selzentry said it
should be an option for doctors to consider, but not necessarily
the first choice for newly diagnosed patients. They said the
product appears to be better-tolerated than many other HIV
treatments.
-By Jennifer Corbett Dooren, Dow Jones Newswires; 202-862-9294;
jennifer.corbett@dowjones.com