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news.Tibotec, has submitted an application to the FDA seeking traditional approval for Intelence tablets, a non-nucleoside reverse transcriptase inhibitor.
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The application for traditional approval includes 48-week data from two Phase III studies known as Duet-1 and Duet-2. Intelence is currently marketed in the US by Tibotec Therapeutics, a division of Centocor Ortho Biotech Products.
Intelence has received accelerated approval in January 2008. As part of the post-marketing commitment, Tibotec is required to submit 48-week data from the Duet studies to the FDA in order for it to consider traditional approval for Intelence.
Intelence, in combination with other antiretroviral agents, is currently 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 non-nucleoside reverse transcriptase inhibitor (NNRTI) and other antiretroviral agents.
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.
Tibotec, is a pharmaceutical research and development company, with headquarters in Ireland and an operating affiliate in Belgium. Tibotec, is dedicated to the discovery and development of novel, new drugs for HIV/AIDS and other infectious diseases.