FDA approved Johnson & Johnson's protease inhibitor Prezista (darunavir) June 23 for treatment-resistant patients with HIV, the agency said. The agent was approved under a priority review.

Prezista is indicated for use in combination with a booster dose of ritonavir "in antiretroviral treatment-experienced adult patients, such as those with HIV-1 strains resistant to more than one protease inhibitor," labeling says.

According to FDA, "ritonavir, which is also a protease inhibitor, slows the metabolism of Prezista, resulting in increased plasma concentrations." The recommended oral dose of Prezista is 600 mg twice daily with 100 mg ritonavir twice daily.

J&J recently announced that it would bulk up its sales force in preparation for Prezista, previously called TMC-114, despite cuts in other business segments (¹ Also see "J&J Pharma Sales Force Reduced As Part Of Efficiencies Program" - Pink Sheet, 19 April, 2006.).

J&amp;J’s Prezista Approved For Treatment-Resistant HIV

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J&J’s Prezista Approved For Treatment-Resistant HIV