Federal health experts have said Pfizer’s HIV drug Selzentry should be approved for use by patients who have not already taken other drugs to combat the virus.
Pharmaceutical company Pfizer is seeking the Food and Drug Administration’s (FDA) approval for its HIV drug to be used as an initial treatment.
At present, Pfizer’s drug Selzentry has been approved as a secondary option for HIV patients who do not respond to other antivirals.
Expert panellists at the FDA voted 10-4 in favour of the new drug despite some inconsistency in the company’s studies of the drug.
When tested against the performance of Bristol-Myers Squibb’s Sustiva it was found to be less effective at suppressing HIV than Sustiva. Later, when Pfizer used a different screening test, it was found to be at least as effective as Sustiva.
The panel of viral experts finally approved the drug saying that it did work, but expressed concerns about the higher levels of viral activity in patients taking Selzentry compared with those on Sustiva.
About 32% of people did not respond to Selzentry, while the number was 24% for Sustiva.
Dr. Russell Van Dyke, of the Tulane University School of Medicine said: “It’s clearly an active drug, it demonstrated effectiveness. But I’m worried it’s not as potent as we might like.”
Copyright Press Association 2009