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U.S. Food And Drug Administration (FDA) Grants Traditional Approval for Intelence (etravirine)

BRIDGEWATER, N.J., Nov. 25 /PRNewswire/ -- The FDA granted traditional approval for Intelence (etravirine) tablets, a non-nucleoside reverse transcriptase inhibitor (NNRTI). Intelence is the only NNRTI specifically indicated for use in treatment-experienced adults who are experiencing virologic failure with HIV-1 strains resistant to an NNRTI and other antiretroviral (ARV) agents. The traditional approval is based on 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.

"With its efficacy and tolerability demonstrated in 48-week studies, etravirine (Intelence) has become an important option for many treatment-experienced patients with resistance to NNRTIs or other antiretrovirals," said DUET clinical investigator Charles Hicks, MD, associate professor of medicine at Duke University's Division of Infectious Diseases in Durham, North Carolina.

Intelence received accelerated approval by the FDA in January 2008 and has been approved in more than 50 countries since then. In January 2009, an application for traditional approval was submitted to the FDA, which included 48-week data from DUET-1 and DUET-2.

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 an NNRTI and other antiretroviral (ARV) agents. This indication is based on Week 48 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 an
      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 DUET studies, identical in design and conducted across the Americas, Australia, Canada, Europe and Thailand, 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 (PIs). 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).

At 48 weeks, significantly more study participants achieved an undetectable viral load (defined as less than 50 HIV-1 RNA copies/mL) with Intelence tablets plus a background regimen compared with placebo plus a background regimen. In the pooled 48-week analysis of DUET-1 and -2, 60 percent of Intelence-treated patients had a confirmed undetectable viral load at 48 weeks compared with 38 percent of placebo-treated patients. In each study, this difference was significant [p<0.0001].

The most commonly reported adverse drug reactions of moderate to severe intensity (greater than or equal to 2 percent) which occurred at a higher rate than placebo were rash (10 percent vs. 3 percent) and peripheral neuropathy (4 percent vs. 2 percent).

The recommended oral dose of Intelence tablets is 200 mg (two 100 mg tablets) taken twice daily following a meal. Patients who are unable to swallow Intelence tablets whole may disperse the tablets in a glass of water.

Important Safety Information

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

  Warnings & Precautions

  --  Severe Skin and Hypersensitivity Reactions:


    - Severe, potentially life-threatening, and fatal skin reactions
      have been reported in patients taking Intelence. These include
      cases of Stevens-Johnson syndrome, toxic epidermal necrolysis, and
      erythema multiforme
    - Hypersensitivity reactions have also been reported and were
      characterized by rash, constitutional findings, and sometimes
      organ dysfunction, including hepatic failure

In the DUET studies, Grade 3 and 4 rashes were reported in 1.3% of patients receiving Intelence compared to 0.2% of patients in the placebo arm. Discontinuation rate due to rash was 2.2% in patients taking Intelence. Rash occurred most commonly during the first 6 weeks of therapy

Discontinue Intelence immediately if signs or symptoms of severe skin reactions or hypersensitivity reactions develop (including, but not limited to, severe rash or rash accompanied by fever, general malaise, fatigue, muscle or joint aches, blisters, oral lesions, conjunctivitis, facial edema, hepatitis, eosinophilia, angioedema)

      - Monitor clinical status including liver transaminases, and
        initiate appropriate therapy
      - Delay in stopping Intelence treatment after the onset of severe
        rash may result in a life-threatening reaction

  --  Fat Redistribution: 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

  Use in Specific Populations

  --  Hepatic Impairment: 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

  Adverse Reactions

  --  The most common adverse drug reactions (greater than or equal to 2%)
      of at least moderate intensity (greater than or equal to Grade 2)
      reported in patients taking Intelence and that occurred at a higher
      rate compared with placebo were rash (10% vs 3%) and peripheral
      neuropathy (4% vs 2%)

  Drug Interactions

  --  Intelence should not be coadministered with the following ARVs:
      tipranavir/ritonavir, fosamprenavir/ritonavir, atazanavir/ritonavir,
      full-dose ritonavir (600 mg bid), protease inhibitors administered
      without low-dose 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 coadministered with
      caution
  --  Coadministration of Intelence with other agents such as substrates,
      inhibitors, or inducers of CYP3A, CYP2C9, CYP2C19, and/or
      P-glycoprotein may alter the therapeutic effect or adverse reaction
      profile of Intelence or the coadministered drug(s). This is not a
      complete list of potential drug interactions

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088

Please see full Prescribing Information for more details. Full prescribing information is also available at www.Intelence-info.com.

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.

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

Source: Tibotec Therapeutics

CONTACT: Media, Pamela Van Houten, +1-908-541-4137, or mobile,
+1-908-295-7367, or Investor Contact, Louise Mehrotra, +1-732-524-6491, or
Lesley Fishman, +1-732-524-3922

Web Site: http://www.Intelence-info.com/

Posted: December 2009

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