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Pfizer's HIV Drug May Be Approved For Secondary Use (PFE)

10/8/2009 - Pfizer's (NYSE:PFE) HIV drug Selzentry may be approved for use by patients who have not already taken other drugs to combat the virus, according to federal health advisers. The FDA's panel of virus experts voted 10-4 in favor of the new use, despite inconsistencies found in the company's studies of the drug. Selzentry is approved as a secondary option for HIV patients who are not responding to other drugs. The FDA's vote came after Pfizer asked the FDA to approve the drug as an initial treatment. The initial study comparing the drug to Bristol-Myers Squibb's (NYSE:BMY) Sustiva failed to meet the goal of being as effective at suppressing HIV as Sustiva. The company then reanalyzed the results and used a different test to screen patients. In the study, the drug did meet its goal. However, the FDA is worried about higher levels of viral activity in patients taking Selzentry versus Sustiva. About 32% of patients did not adequately respond to Selzentry drug, compared to 24% of patients taking Sustiva, according to an AP article. The drug is part of a class of treatments that block HIV from entering white blood cells through a pathway present in some patients.

Write to Chip Brian at cbrian@tradethetrend.com

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Related terms: drugs, federal, health, hiv, market, nyse, securities

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