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news.Tibotec Pharmaceuticals has reported that the FDA has granted accelerated approval to the anti-HIV medication Intelence tablets – the first non-nucleoside reverse transcriptase inhibitor to show antiviral activity in treatment-experienced adult patients with HIV resistant to a NNRTI and other antiretroviral agents.
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The Intelence approval is based on the 24-week analysis of HIV viral load and CD4+ cell counts from the pooled analysis of the Duet studies. This indication is based on week 24 analyses from two randomized, double-blind, placebo-controlled trials of Intelence. Both studies were conducted in clinically advanced, three-class antiretroviral (NNRTI, N[t]RTI, PI) treatment-experienced adults.
Intelence, in combination with other antiretroviral agents, is indicated for the treatment of human immunodeficiency virus type 1 (HIV-1) infection in antiretroviral treatment-experienced adult patients, who have evidence of viral replication and HIV-1 strains resistant to a NNRTI and other ARV agents.
Intelence, also known as TMC125, was developed by Tibotec Pharmaceuticals and will be marketed in the US by Tibotec Therapeutics, a division of Ortho Biotech Products.
Richard Haubrich, investigator in the Intelence Phase III Duet studies, said: “Etravirine breaks new ground in the NNRTI class, and provides a new option to thousands of treatment-experienced patients with NNRTI-resistant HIV.”