Most Recent Events

• 29 Jan 2025 According to a Johnson & Johnson media release, based on results from PAINT and PICTURE studies, the European Commission 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 class and with a viral load less than equal to 100,000 HIV- RNA copies/ml.
• 19 Mar 2024 According to a Johnson & Johnson media release, company announced that the U.S. Food and Drug Administration (FDA) has approved EDURANT PED (rilpivirine) for the treatment of HIV-1 in combination with other antiretroviral therapies (ARVs) in treatment-naive 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 based on the results of PAINT (NCT00799864) and PICTURE (NCT04012931) studies.
• 28 Jul 2023 According to Janssen media release, the company announced the submission of a supplemental New Drug Application to the U.S. Food and Drug Administration (FDA) seeking to expand the indication of EDURANT (rilpivirine) to include the treatment of HIV-1 infection in children weighing 10 kg or more. A parallel Marketing Authorization application has also been submitted to the European Medicines Agency (EMA) in support of a type II variation and line extension for expanded pediatric use in Europe.