FDA approves labeling update for HIV drug
BRIDGEWATER, N.J. Tibotec Therapeutics announced Thursday that the Food and Drug Administration has approved a labeling update for its HIV drug tablets to include 96-week data from the two studies.
The two studies, Artemis and Titan, examined the efficacy of Prezista (darunavir) with ritonavir vs. lopinavir in combination with other antiretrovirals for the treatment of HIV-1 in treatment-naive and treatment-experienced adult patients, respectively.
This indication is based on analyses of plasma HIV RNA levels and CD4+ cell counts from two controlled Phase 3 trials of 48 weeks duration in antiretroviral treatment-naive and treatment-experienced patients and two controlled Phase 2 trials of 96 weeks duration in clinically advanced, treatment-experienced adult patients.
"The addition of this information to the Prezista label demonstrates our commitment to providing information on the durability and safety profile of our medications over the long-term. In addition, Tibotec continues to invest in its long-standing research and development efforts to bring new options to people living with HIV," said Glenn Mattes, Tibotec Therapeutics president.