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Tibotec Submits Application to U.S. Food and Drug Administration Seeking Traditional Approval for Intelence (etravirine)

BRIDGEWATER, N.J., February 05, 2009 /PRNewswire/ -- Tibotec, Inc. today announced it has submitted an application to the U.S. Food and Drug Administration (FDA) seeking traditional approval for Intelence (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:

The traditional approval filing includes the 48-week efficacy and safety results of DUET-1 and DUET-2, two Phase 3 randomized, placebo-controlled studies that examined the use of Intelence in combination with other antiretroviral agents in adult treatment-experienced HIV-1 patients with documented resistance to NNRTIs and protease inhibitors. Participants in the DUET studies were randomized to receive Intelence 200 mg twice daily or placebo, each given in addition to a background regimen. For all patients, the BR included darunavir/ritonavir, plus at least two investigator-selected antiretroviral drugs (N(t)RTIs with or without enfuvirtide). Forty-eight-week data from this study were presented at the 15th Conference on Retroviruses and Opportunistic Infections in Boston on February 7, 2008.

Intelence does not cure HIV infection or AIDS, and does not prevent passing HIV to others.

Tibotec, Inc., based in Cork, Ireland, is a pharmaceutical research and development company. The Company's main research and development facilities are in Mechelen, Belgium with offices in Yardley, PA. Tibotec is dedicated to the discovery and development of innovative HIV/AIDS drugs and anti-infectives for diseases of high unmet medical need.

Tibotec Therapeutics, a division of Centocor Ortho Biotech Products, L.P., headquartered in Bridgewater, N.J., is dedicated to delivering innovative virology therapeutics that help healthcare professionals address serious unmet needs in people living with HIV.

Centocor Ortho Biotech Products, L.P. and Tibotec Pharmaceuticals are subsidiaries of Johnson & Johnson.

CONTACT: Media, Pamela Van Houten, Office, +1-908-541-4137, or Mobile,+1-908-295-7367; or Investors, Louise Mehrotra, +1-732-524-6491, or LesleyFishman, +1-732-524-3922

Web site: http://www.intelence-info.com/

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Posted: February 2009

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