US FDA grants J&J's Prezista expanded label
The US Food and Drug Administration has granted Johnson & Johnson's protease inhibitor Prezista (darunavir) an expanded indication for once-daily dosing as part of HIV combination therapy in treatment-naive adults.
The FDA also granted full approval to the agent, which was developed by Tibotec, a unit of J&J, for use twice-daily in treatment-experienced adult patients.
Costing almost $10,000 per patient per year, the drug received accelerated approval in June 2006 for use in combination with other antiretrovirals in treatment-experienced adult patients, such as those with HIV-1 that is resistant to more than one protease inhibitor. This indication is based on analyses of plasma HIV RNA levels and CD4+ cell counts from two controlled, 48-week, Phase III trials.
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