Important note: Information in this article was accurate in 2009. The state of the art may have changed since the publication date.
Associated Press - October 8, 2009
The Food and Drug Administration's panel of virus experts voted 10-4 in favor of the new use, despite some inconsistency in company studies of the drug. Selzentry is approved as a secondary option for HIV patients who are not responding to other antiviral drugs. New York-based Pfizer is asking the FDA to approve the drug as an initial treatment.
Pfizer's initial study comparing Selzentry with Bristol-Myers Squibb's Sustiva failed to meet the goal of showing it was at least as effective at suppressing HIV.
But when Pfizer reanalyzed the results using a different test to screen patients, the study met its goal.
FDA reviewers raised concerns about higher levels of viral activity in patients taking Selzentry compared with Sustiva. About 32 percent of patients did not adequately respond to Pfizer's drug, compared with 24 percent of patients taking the alternative.
A majority of panelists ultimately said the drug works and should be made available as an option for patients, though they expressed lingering concerns about the strength of its effect.
"It's clearly an active drug, it demonstrated effectiveness," said Dr. Russell Van Dyke, of the Tulane University School of Medicine. "But I'm worried it's not as potent as we might like."
Other panelists said they were not comfortable backing a product that could be inferior to drugs already on the market.
"There's a lot that's promising about this drug, but this trial doesn't convince me," said Dr. Barbara McGovern, of Tufts University Medical School.
Panelists said Pfizer should continue collecting data on the drug's effectiveness, particularly in minority populations.
While the FDA is not permitted to consider cost when deciding whether to approve a drug, several panelists commented on Selzentry's high price tag.
If approved, Selzentry would be the most expensive first-line HIV treatment on the U.S. market, according to the AIDS Healthcare Foundation, a nonprofit patient advocacy group. Selzentry's wholesale price per year is over $12,500, according to the group, compared with $4,800 for Bristol-Myers' Sustiva.
The FDA is not required to follow the advice of its panels, though it usually does.
Selzentry is part of a recently developed class of treatments that block HIV from entering white blood cells through a pathway present in some patients. While more than 1 million people in the U.S. are HIV positive, only a subset of that group respond to Pfizer's pill. The drug works by blocking the so-called CCR5 receptor.
HIV attacks the body's immune system, eventually causing AIDS.
Pfizer said the meeting "marks an important step in expanding available treatment options for patients with HIV infection."
Selzentry had sales of $46 million last year, according to Pfizer.
091008
AP091009
Copyright © 2009 - Associated Press. Reproduction of this article (other than one copy for personal reference) must be cleared through the AP Permissions Desk.
AEGiS is a 501(c)3, not-for-profit, tax-exempt, educational corporation. AEGiS is made possible through unrestricted funding from Broadway Cares/Equity Fights AIDS, Elton John AIDS Foundation, National Library of Medicine, and donations from users like you.
Always watch for outdated information. This article first appeared in 2009. This material is designed to support, not replace, the relationship that exists between you and your doctor.
AEGiS presents published material, reprinted with permission and neither endorses nor opposes any material. All information contained on this website, including information relating to health conditions, products, and treatments, is for informational purposes only. It is often presented in summary or aggregate form. It is not meant to be a substitute for the advice provided by your own physician or other medical professionals. Always discuss treatment options with a doctor who specializes in treating HIV.
Copyright ©1980, 2009. AEGiS. All materials appearing on AEGiS are protected by copyright as a collective work or compilation under U.S. copyright and other laws and are the property of AEGiS, or the party credited as the provider of the content. .