U.S. Food and Drug Administration (FDA) has approved Intelence (etravirine) 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 years to <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 approval, which follows FDA priority review of the company’s supplemental New Drug Application, expands the Intelence indication and 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 approval includes a new 25mg dose to allow for weight-based dosing in pediatric patients (6 years to <18 years old and weighing at least 16kg or 35.2 lbs). The 25mg tablet is expected to be available in the first half of May.
