October 9, 2009
Although some of its members expressed "ambivalence" and "doubt," an advisory panel to the Food and Drug Administration on Thursday voted 10-4 to endorse expanded use of Pfizer Inc.'s HIV drug Selzentry (maraviroc).
Selzentry is already approved for use, along with other HIV drugs, by adult patients who have been treated with antiretrovirals and developed resistance to them. Final FDA approval of the new application would allow the drug to be prescribed for previously untreated adults infected with chemokine (c-c motif) receptor 5 (CCR5) tropic HIV-1.
Panelist Dr. Victoria Cargill, who heads minority research at the National Institutes of Health's Office of AIDS Research, voted for the new use. "We're not looking for the absolute best, we're looking for an option," she said.
However, some panelists said Pfizer's data -- which compared Selzentry to efavirenz -- were underwhelming, and they cited concerns about side effects. "We have several first-line options available to us in 2009. I'm not convinced that this drug is my first choice" for treatment-naïve patients, said Dr. Barbara McGovern, a professor of medicine at Tufts University School of Medicine. She voted against expanded approval.
Cost is not a factor in FDA's approval decisions, but after the vote several advocates called on Pfizer to cut the price of Selzentry, which has risen 10 percent -- to $13,767 per year per patient -- since its initial approval in 2007.
The panelists asked Pfizer to amass more data on Selzentry, including its effect on pregnant women and patients co-infected with hepatitis or TB. They also asked FDA officials to label the drug so as to make its limitations clear. Pfizer said it would work with FDA on the label language. Pfizer expects FDA's final decision by Nov. 20.