J&J’s Edurant PED Approved for Pediatric HIV-1

FDA has approved Johnson & Johnson’s Edurant PED (rilpivirine) for treating HIV-1 in combination with other antiretroviral therapies (ARVs) in treatment-naïve children at least two years of age and weighing at least 14 kg and less than 25 kg. The approval is based on data from the PAINT (NCT00799864) and PICTURE (NCT04012931) studies in pediatric subjects, “which showed that rilpivirine, in combination with other ARVs, effectively suppresses the virus in treatment-naïve (with HIV-1 RNA <100,000 copies/mL) pediatric patients,” the company says.

 Rilpivirine is described as a non-nucleoside reverse transcriptase inhibitor. It previously was indicated for use in combination with Vocabria (cabotegravir) for short-term treatment of HIV-1 infection in certain adults and adolescents 12 years and older and weighing at least 35 kg who are virologically suppressed.