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Tibotec Submits Application to U.S. Food and Drug Administration Seeking Traditional Approval for INTELENCE(TM) (etravirine)
Date:2/5/2009

BRIDGEWATER, N.J., Feb. 5 /PRNewswire/ -- Tibotec, Inc. today announced it has submitted an application to the U.S. Food and Drug Administration (FDA) seeking traditional approval for INTELENCE(TM) (etravirine) tablets, a non-nucleoside reverse transcriptase inhibitor (NNRTI). The application for traditional approval includes 48-week data from two Phase 3 studies known as DUET-1 and DUET-2. INTELENCE is currently marketed in the U.S. by Tibotec Therapeutics, a division of Centocor Ortho Biotech Products, L.P.

INTELENCE 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 NNRTI and other antiretroviral (ARV) 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.

The following points should be considered when initiating therapy with INTELENCE:

  • Treatment history and, when available, resistance testing, should guide the use of INTELENCE.
  • The use of other active antiretroviral agents with INTELENCE is associated with an increased likelihood of treatment response.
  • In patients who have experienced virologic failure on a NNRTI-containing regimen, do not use INTELENCE in combination with only N[t]RTIs.
  • The risks and benefits of INTELENCE have not been estab
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SOURCE Tibotec, Inc.
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