Tibotec Submits Application to U.S. Food and Drug Administration Seeking Traditional Approval for Intelence™ (Etravirine)
Yardley, PA, – Tibotec, Inc. today announced it has submitted an application to the U.S. Food and Drug Administration (FDA) seeking traditional approval for INTELENCETM (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-naïve adult patients.
DUET-1 AND DUET-2
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 (less than 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 (more than 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).
* 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 www.INTELENCE-info.com.
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