European Commission Approves Expanded Use of HIV-1 Therapy EDURANT® (rilpivirine) in Younger Pediatric Patients
Approval provides a new treatment option for some of the youngest people living with HIV-1 in the European Union
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.
About Johnson & Johnson
At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at https://www.jnj.com/. Janssen Research & Development, LLC is a Johnson & Johnson company.
Cautions Concerning Forward-looking Statements
This press release contains “forward-looking statements” as defined in the Private Securities Litigation Reform Act of 1995. The reader is cautioned not to rely on these forward-looking statements. These statements are based on current expectations of future events. If underlying assumptions prove inaccurate or known or unknown risks or uncertainties materialize, actual results could vary materially from the expectations and projections of Janssen-Cilag International NV, Janssen Pharmaceutica NV, Janssen Research & Development, LLC and/or Johnson & Johnson. Risks and uncertainties include, but are not limited to: challenges and uncertainties inherent in product research and development, including the uncertainty of clinical success and of obtaining regulatory approvals; uncertainty of commercial success; manufacturing difficulties and delays; competition, including technological advances, new products and patents attained by competitors; challenges to patents; product efficacy or safety concerns resulting in product recalls or regulatory action; changes in behavior and spending patterns of purchasers of health care products and services; changes to applicable laws and regulations, including global health care reforms; and trends toward health care cost containment. A further list and descriptions of these risks, uncertainties and other factors can be found in Johnson & Johnson’s Annual Report on Form 10-K for the fiscal year ended December 31, 2023, including in the sections captioned “Cautionary Note Regarding Forward-Looking Statements” and “Item 1A. Risk Factors,” and in Johnson & Johnson’s subsequent Quarterly Reports on Form 10-Q and other filings with the Securities and Exchange Commission. Copies of these filings are available online at www.sec.gov, www.jnj.com or on request from Johnson & Johnson. None of Janssen-Cilag International NV, Janssen Pharmaceutica NV, Janssen Research & Development, LLC nor Johnson & Johnson undertakes to update any forward-looking statement as a result of new information or future events or developments.
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Source: Johnson & Johnson
https://www.jnj.com/media-center/press-releases/european-commission-approves-expanded-use-of-hiv-1-therapy-edurant-rilpivirine-in-younger-pediatric-patients
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