USFDA nod to Johnson and Johnson EDURANT PED for certain pediatric patients living with HIV-1

“Decades of experience with the global HIV epidemic have made it clear that new and improved treatment options are needed to support the diverse population of people living with HIV on their treatment journey,” said Penny Heaton, M.D., Global Therapeutic Area Head, Infectious Diseases and Vaccines at Johnson & Johnson. “While the population of young children living with HIV is small, additional treatment options remain key to ensuring that each person living with HIV can be matched to a treatment regimen that is right for them.”

The FDA’s decision is based on results 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. Rilpivirine can be administered to children at least 2 years of age and weighing at least 25 kg via standard 25 mg oral tablets (EDURANT) or new 2.5 mg oral tablets (EDURANT PED) that were developed to aid administration and weight-adjusted dosing for children.

EDURANT and EDURANT PED are a human immunodeficiency virus type 1 (HIV-1) specific, non-nucleoside reverse transcriptase inhibitor (NNRTI) indicated in combination with other antiretroviral agents for the treatment of HIV-1 infection in treatment naïve patients at least 2 years of age and weighing at least 14 kg with HIV-1 RNA less than or equal to 100,000 copies/mL.

Limitations of Use:

• More EDURANT treated subjects with HIV-1 RNA greater than 100,000 copies/mL at the start of therapy experienced virologic failure (HIV-1 RNA ≥50 copies/mL) compared to EDURANT treated subjects with HIV-1 RNA less than or equal to 100,000 copies/mL.

EDURANT is indicated in combination with VOCABRIA (cabotegravir), for short-term treatment of HIV-1 infection in adults and adolescents 12 years and older and weighing at least 35 kg who are virologically suppressed (HIV-1 RNA less than 50 copies/mL) on a stable regimen with no history of treatment failure and with no known or suspected resistance to either cabotegravir or rilpivirine.