Navigation Links
Tibotec Submits Application to U.S. Food and Drug Administration Seeking Traditional Approval for INTELENCE(TM) (etravirine)

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 established in pediatric patients or in treatment-naive adult patients.


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.

Important Safety Information

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

  • Severe and potentially life-threatening skin reactions, including Stevens-Johnson Syndrome, hypersensitivity reaction, and erythema multiforme, have occurred (<0.1 percent) in patients taking INTELENCE. Treatment with INTELENCE should be discontinued and appropriate therapy initiated if severe rash develops.
  • In general, in clinical trials, rash was mild to moderate, occurred primarily in the second week of therapy, and was infrequent after Week 4. Rash generally resolved within 1-2 weeks on continued therapy. Discontinuation rate due to rash was two percent.
  • Redistribution and/or accumulation of body fat have been observed in patients receiving antiretroviral (ARV) therapy. The causal relationship, mechanism, and long-term consequences of these events have not been established.
  • Immune reconstitution syndrome has been reported in patients treated with ARV therapy, including INTELENCE.
  • INTELENCE should be used with caution in patients with severe hepatic impairment (Child-Pugh class C) as pharmacokinetics of INTELENCE have not been evaluated in these patients.
  • The most common adverse events (>10 percent) of any intensity that occurred at a higher rate than placebo at 24-weeks were rash (16.9 percent vs. 9.3 percent) and nausea (13.9 percent vs. 11.1 percent).
  • The most common treatment-emergent adverse reactions (Grade 2-4) that occurred in patients receiving an INTELENCE-containing regimen vs. placebo at 24-weeks were rash (9.0 percent vs. 3.1 percent), diarrhea (5.2 percent vs. 9.6 percent), nausea (4.7 percent vs. 3.5 percent), fatigue (3.3 percent vs. 4.0 percent), abdominal pain (3.0 percent vs. 2.5 percent), peripheral neuropathy (2.8 percent vs. 1.8 percent), hypertension (2.8 percent vs. 2.2 percent), headache (2.7 percent vs. 4.1 percent), and vomiting (2.3 percent vs. 2.0 percent).

Drug Interactions

  • INTELENCE should not be co-administered with the following ARVs: tipranavir/ritonavir, fosamprenavir/ritonavir, atazanavir/ritonavir, full-dose ritonavir (600 mg bid), protease inhibitors administered without ritonavir, and other NNRTIs.
  • INTELENCE should not be co-administered with carbamazepine, phenobarbital, phenytoin, rifampin, rifapentine, rifabutin (when part of a regimen containing protease inhibitor/ritonavir) or products containing St. John's wort (Hypericum perforatum).
  • INTELENCE and lopinavir/ritonavir should be co-administered with caution.
  • Co-administration of INTELENCE with other agents such as substrates, inhibitors, or inducers of CYP3A4, CYP2C9, and/or CYP2C19 may alter the therapeutic effect or adverse events profile of INTELENCE or the co-administered drug(s). This is not a complete list of potential drug interactions.

Please see full Prescribing Information for more details. Full prescribing information is also available at

About Tibotec, Inc.

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.

About Tibotec Therapeutics

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.

(This press release contains "forward-looking statements" as defined in the Private Securities Litigation Reform Act of 1995. These statements are based on current expectations of future events. If underlying assumptions prove inaccurate or unknown risks or uncertainties materialize, actual results could vary materially from the Company's expectations and projections. Risks and uncertainties include general industry conditions and competition; economic conditions, such as interest rate and currency exchange rate fluctuations; technological advances and patents attained by competitors; challenges inherent in new product development, including obtaining regulatory approvals; domestic and foreign health care reforms and governmental laws and regulations; and trends toward health care cost containment. A further list and description of these risks, uncertainties and other factors can be found in Exhibit 99 of Johnson & Johnson's Annual Report on Form 10-K for the fiscal year ended December 30, 2007. Copies of this Form 10-K, as well as subsequent filings, are available online at, or on request from Johnson & Johnson. The Company does not undertake to update any forward-looking statements as a result of new information or future events or developments.)

    Media Contact:  Pamela Van Houten     Investor Contact:  Louise Mehrotra
                    Office: 908-541-4137                     (732) 524-6491
                    Mobile: 908-295-7367                     Lesley Fishman
                                                             (732) 524-3922

SOURCE Tibotec, Inc.
Copyright©2009 PR Newswire.
All rights reserved

Related medicine news :

1. Tibotec and Emcure Collaborate on Access to Darunavir for India
2. Tibotec presents interim findings for TMC435, an investigational genotype 1 hepatitis C treatment
3. Tibotec Pharmaceuticals a Respectful Partner to HIV Community in Pricing of Novel New HIV NNRTI, INTELENCE
4. Interleukin Genetics Submits Plan to Regain Compliance with Continued Listing Standards
5. STERIS Corporation Submits New Sterilization System To FDA and Announces Developments on SYSTEM 1 Warning Letter
6. TriServ Alliance Submits Final Bid for TRICARE South Region Contract
7. WorldHeart Submits IDE Application for a Pivotal Bridge-to-Transplant Study of the Levacor(TM) VAD
8. Biopure Submits IND Application for Proposed Clinical Trial in Patients with Acute Myeloid Leukemia
9. ViroPharma Submits Supplemental Biologics License Application for Cinryze(TM) to Treat Acute Attacks of Hereditary Angioedema
10. SCOLR Pharma, Inc. Submits Abbreviated New Drug Application for a 12-hour CDT-based Pseudoephedrine Formulation
11. TriServ Alliance Submits Bid for TRICARE South Region Contract
Post Your Comments:
(Date:11/27/2015)... ... November 27, 2015 , ... According to an ... the University of Toronto and the University of British Columbia suggested that laws requiring ... injuries. The article explains that part of the reason for the controversial conclusion is ...
(Date:11/27/2015)... (PRWEB) , ... November 27, 2015 , ... ... a safe and convenient way to dispense prescription medications at home, so he ... effective way to monitor and dispense prescription medications. In doing so, it could ...
(Date:11/27/2015)... ... 27, 2015 , ... ProSidebar: Fashion is a set of 30 ... ProSidebar: Fasion, video editors can easily add an informative sidebar to any FCPX production. ... Utilize presets featuring self-animating drop zones, lines, bars, and text with the ease of ...
(Date:11/27/2015)... (PRWEB) , ... November 27, 2015 , ... A simply ... Jones, is an interesting show that delves into an array of issues that are ... that could benefit from open dialogue, this show is changing the subjects consumers focus ...
(Date:11/27/2015)... ... November 27, 2015 , ... ... successful and prominent nonprofit healthcare organizations in the country. They have overseen financial ... organizations, and helped advance the healthcare industry as a whole through their advocacy ...
Breaking Medicine News(10 mins):
(Date:11/26/2015)... , November 26, 2015 ... "Self Administration of High Viscosity Drugs" ... ) has announced the addition of the ... to their offering. --> Research and ... of the "Self Administration of High Viscosity ...
(Date:11/25/2015)... total global healthcare industry is expected to grow at a ... has the highest projected growth at 12.7%, and ... ), is second with growth projected at 11.5%. ... In 2013-2014, total government funded healthcare was nearly 68%. Federal ... in 2013-2014. In real terms, out of pocket expenditure increased ...
(Date:11/25/2015)... -- On Tuesday, November 24, 2015, the jury ... Medical Technology, Inc. for product liability and misrepresentation ... device, awarded $11 million in favor of Plaintiff ... three days of deliberations, the jury found that ... and unreasonably dangerous, and that Wright Medical made ...
Breaking Medicine Technology: