October 7, 2009
FDA Says New Pfizer HIV Drug Appears Safe
On Tuesday, the Food and Drug Administration (FDA) announced that an HIV drug made by Pfizer appears to be safe for expanded use in patients who have not began taking other drugs to fight the terrible virus.
The drug Selzentry had already been approved by the FDA as a secondary option for HIV patients who are not getting better with other antiviral drugs, but the company is now seeking the FDA's approval for the drug to be the first-choice of treatment.Tuesday's online posting of briefing documents indicated that FDA scientists are in favor of the new use for the drug.
It was said in the review that "no new safety signals were identified in association" with the drug.
Though there is a warning on the Selzentry packaging about potential liver toxicity, FDA reviewers claim that reports of these events occurring have been low in company trials.
The FDA will request on Thursday that a panel of outside viral experts take a vote on the safety and effectiveness of Selzentry. The agency typically follows the group's advice, even though it does not have to.
Selzentry is currently part of a newly developed class of treatments that block HIV from entering white blood cells via a pathway present in some patients. Over one million people in the U.S. are HIV positive, but only a portion of that group respond to Pfizer's pill.
The receptor that Selzentry blocks is the "CCR5" receptor. HIV overwhelms the body's immune system, and eventually leads to AIDS.
In the online posted briefing documents, the New York-based company said "there is a continuing medical need for a range of safe and well tolerated" anti-HIV drugs.
Pfizer reported that Selzentry made $46 million in last year's sales alone.
Morning trading showed that Pfizer shares were up 44 cents, or 2.7 percent, to $16.84.
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