The FDA has granted Prezista (darunavir) tablets approval for an expanded indication for once-daily dosing as part of HIV combination therapy in treatment-naive adults.
The FDA also granted full approval to Prezista as a twice-daily therapy for treatment-experienced adult patients. Prezista – a protease inhibitor – was developed by Tibotec Pharmaceuticals and is marketed in the US by Tibotec Therapeutics.
In June 2006, Prezista received accelerated approval for use in combination with other antiretrovirals (ARVs) in treatment-experienced adult patients, such as those with HIV-1 that is resistant to more than one protease inhibitor.
Following this most recent approval, Prezista is now indicated for the treatment of human immunodeficiency virus (HIV-1) infection.
This indication is based on analyses of plasma HIV RNA levels and CD4+ cell counts from two controlled phase III trials of 48 weeks duration in antiretroviral treatment-naive and treatment-experienced patients and two controlled phase II trials of 96 weeks duration in clinically advanced, treatment-experienced patients.
The risks and benefits of Prezista have not been established in pediatric patients. No clinical studies have demonstrated the effect of Prezista on clinical progression of HIV-1.
The traditional approval is based on 48-week data from the ARTEMIS and TITAN phase III non-inferiority studies and 96-week safety and efficacy data from the phase IIb POWER studies.
Both ARTEMIS and TITAN studied the efficacy and safety of PREZISTA/r vs. lopinavir/r in combination with other ARVs.