FDA Approves New Indication for Intelence

Janssen Therapeutics March 27 announced that the Food and Drug Administration has approved an expansion of the indication for Intelence (etravirine).

The new approval is for administration in combination with other antiretroviral medications (ARVs) for the treatment of HIV-1 in treatment-experienced pediatric patients who are experiencing virologic failure with HIV-1 strains resistant to a non-nucleoside reverse transcriptase inhibitor (NNRTI) and other ARVs. The approval makes it the only NNRTI indicated for this use in both treatment-experienced children and adults with resistance to an NNRTI and other ARVs, the Titusville, N.J.-based company said. Janssen Therapeutics is part of Johnson & Johnson. ...