European Commission Approves Expanded Use of HIV-1 Therapy EDURANT^® (rilpivirine) in Younger Pediatric Patients

Beerse, Belgium (October 28, 2024) – Johnson & Johnson today announced that the European Commission (EC) has approved EDURANT^® (rilpivirine) for the treatment of HIV-1 infection in adults and children weighing at least 25 kg without known mutations associated with resistance to the non-nucleoside reverse transcriptase inhibitor (NNRTI) class and with a viral load ≤ 100,000 HIV‑1 RNA copies/ml. To support expanded pediatric use, new 2.5 mg dispersible tablets have been developed for weight-adjusted dosing in children 2 to less than 18 years of age, weighing at least 14 kg and less than 25 kg.

“For years, we have worked to safeguard a future where no one is limited by an HIV diagnosis just because of their age,” says Brian Woodfall, Global Head of End-to-End Development, Communicable Diseases. “This approval will help ensure that some of the youngest people living with HIV have another treatment option that can work for them.”

The EC’s decision was supported by results from the Phase 2b PAINT (NCT00799864) and PICTURE (NCT04012931) studies, which showed no new safety findings compared with the known safety profile of rilpivirine and that rilpivirine, in combination with other antiretroviral (ARV) therapies, was effective at achieving or maintaining virological suppression in treatment-experienced and -naïve pediatric patients. This approval follows the July 2024 positive opinion from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) and the March 2024 U.S. FDA approval of rilpivirine for select pediatric patients.

About EDURANT^® (rilpivirine) 25mg
EDURANT^®, in combination with other antiretroviral medicinal products, is indicated for the treatment of human immunodeficiency virus type 1 (HIV‑1) infection in adults and pediatric patients weighing at least 25 kg without known mutations associated with resistance to the non-nucleoside reverse transcriptase inhibitor (NNRTI) class, and with a viral load ≤ 100,000 HIV‑1 RNA copies/ml. Genotypic resistance testing should guide the use of EDURANT ^®.

About EDURANT^® (rilpivirine) 2.5mg
EDURANT^® is also available as 2.5 mg tablets for the treatment of human immunodeficiency virus type 1 (HIV‑1) infection in pediatric patients 2 to less than 18 years of age and weighing at least 14 kg and less than 25 kg without known mutations associated with resistance to the non-nucleoside reverse transcriptase inhibitor (NNRTI) class, and with a viral load ≤ 100,000 HIV‑1 RNA copies/ml. The recommended dosage of EDURANT^® in these pediatric patients is based on body weight.

For details on clinical particulars, including contraindications, special warnings and precautions for use and interaction with other medicinal products and other forms of interaction, please refer to the Summary of Product Characteristics.

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