Intelence granted traditional approval by FDA for HIV

Tibotec announced that the FDA has granted traditional approval for Intelence (etravirine) tablets, a non-nucleoside reverse transcriptase inhibitor (NNRTI), 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 was based on 48-week data from two Phase 3 clinical studies, DUET-1 and DUET-2. At 48 weeks, significantly more patients achieved an undetectable viral load with Intelence plus a background regimen compared with placebo plus a background regimen. A pooled analysis of DUET-1 and DUET-2, showed 60% of Intelence-treated patients had a confirmed undetectable viral load at 48 weeks compared with 38% of placebo-treated patients (p<0.0001).

Intelence first received accelerated approval by the FDA in January 2008.

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