FDA panel backs broader Selzentry use

Good news for Pfizer's HIV drug Selzentry. An FDA advisory panel yesterday recommended broader use of the med, which is currently only approved for patients whose treatment on other drugs has failed. If the agency ratifies its expert advisors' opinion--and it usually does--Selzentry can be marketed as a first-line treatment for patients with one major strain of the virus.

Some panel members were less than impressed with the supporting data, however, expressing concerns about the number of study dropouts and the incidence of drug resistance. The desire to offer doctors and patients another treatment option overrode those concerns. "We're not looking for the absolute best, we're looking for an option," said panelist Dr. Victoria Cargill of the NIH AIDS research office (as quoted by Reuters). 

Panelists offered a couple of suggestions: That FDA detail Selzentry's limitations on its label. And that Pfizer conduct additional research on the drug's effects on pregnant women, and on patients with hepatitis or tuberculosis. After the panel's vote, consumer advocates called on the company to lower Selzentry's price as well.

Selzentry's price has risen 10 percent since its approval two years ago, to $13,767 per year, the AIDS Healthcare Foundation said. "[I]t is simply criminal for Pfizer to continue to price Selzentry at the salvage therapy rate," foundation president Michael Weinstein said in a statement. " [W]e urge Pfizer to use restraint and to lower the price of Selzentry immediately upon FDA approval for this expanded use."

- read the AHF release
- see the news at PharmaTimes
- get more from Reuters

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Selzentry approval marks big win for Pfizer (2007)