U.S. FDA approves EDURANT PED for pediatric patients living with HIV-1

The U.S. Food and Drug Administration (FDA) has approved Johnson & Johnson’s EDURANT® PED (rilpivirine) for the treatment of HIV-1 in combination with other antiretroviral therapies (ARVs) in treatment-naïve children (with HIV-1 RNA <100,000 copies/mL) at least 2 years of age and weighing at least 14 kg and less than 25 kg.

“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 and PICTURE 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.

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