October 23, 2008
Tibotec Announces FDA Approval for Expanded Indication of HIV Drug
Tibotec Therapeutics has announced that the FDA has granted Prezista tablets, a protease inhibitor, approval for an expanded indication for once-daily dosing as part of HIV combination therapy in treatment-naive adults.
The FDA also granted traditional (full) approval to Prezista as twice-daily for use in treatment-experienced adult patients. Prezista was developed by Tibotec Pharmaceuticals and is marketed in the US by Tibotec Therapeutics, a division of Ortho Biotech Products.Previously, 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 the latest approval, Prezista, co-administered with 100mg ritonavir (Prezista/r), and with other antiretroviral agents, is 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 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 versus lopinavir/r in combination with other ARVs.
Glenn Mattes, president of Tibotec Therapeutics, said: "Tibotec is proud to reach this important milestone that makes Prezista available to those who are just starting HIV treatment for the first time. We look forward to continuing to provide treatment options that will add to the arsenal of anti-HIV therapies."