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FDA Grants Traditional Approval for Etravirine (Intelence)

On November 24, the U.S. Food And Drug Administration (FDA) granted traditional approval of Tibotec's next-generation non-nucleoside reverse transcriptase inhibitor etravirine (Intelence), based on longer-term data from 2 pivotal trials showing that the drug was safe and effective over 48 weeks in treatment-experienced HIV patients with resistant virus.

Below is an excerpt of a press release from Tibotec announcing the approval.

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

Bridgewater, NJ -- November 25, 2009 -- 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 [BR]. For all patients, the BR included darunavir/ritonavir [Prezista] 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.

The full announcement, including comprehensive etravirine safety information, is available online.

Researchers reported 96-week safety data for etravirine last month at the annual meeting of the Infectious Diseases Society of America (IDSA 2009) and at European AIDS Conference (EACS 2009).

For further information about Tibotec, visit http://www.tibotec.com.

12/1/09

Sources

Tibotec Therapeutics. U.S. Food And Drug Administration (FDA) Grants Traditional Approval for Intelence (etravirine). Press release. November 25, 2009.

R Klein and K Struble (FDA Division of Antiviral Drug Products). HIV/AIDS Update -Intelence (etravirine) label updated to reflect dosing data through 48 weeks. Email announcement. November 25, 2009.