Janssen Therapeutics announced that the FDA has approved Intelence (etravirine) tablets to be administered in combination with other antiretroviral (ARV) medications for treatment of human immunodeficiency virus 1 (HIV-1) in treatment-experienced pediatric patients (6–<18 years old) who are experiencing virologic failure with HIV-1 strains resistant to a non-nucleoside reverse transcriptase inhibitor (NNRTI) and other ARVs.
This new indication makes Intelence the only NNRTI approved for use in both treatment-experienced children and adults with resistance to an NNRTI and other ARVs. The approval includes a new 25mg dosage strength to allow for weight-based dosing in pediatric patients (6–<18 years old and weighing >16kg or 35.2lbs).
The approval is based on 24-week data from the PIANO (Pediatric trial with Intelence as an Active NNRTI Option) study, which evaluated the pharmacokinetics, safety, tolerability and efficacy of Intelence in combination with other ARVs in antiretroviral treatment-experienced pediatric patients 6–<18 years old.
Intelence 25mg tablets are expected to be available in the first half of May. Intelence is already available in 100mg and 200mg dosage strength tablets.
For more information call (800) 526-7736 or visit www.intelence-info.com.