European Commission Greenlights Expanded HIV-1 Treatment for Children with EDURANT®

Johnson & Johnson Expands HIV-1 Therapy EDURANT® for EU’s Youngest Patients, Offering New Hope.

The European Commission approved the use of EDURANT® (rilpivirine) for pediatric HIV-1 treatment across the EU. This decision offers a new, targeted therapy for younger HIV patients. Children aged 2 to under 18 now have an option specifically designed for their needs.

Johnson & Johnson announced and introduced a 2.5 mg dispersible tablet form of EDURANT®. This version targets children weighing between 14 and 25 kg.

Brian Woodfall, Global Head of End-to-End Development for Communicable Diseases at Johnson & Johnson, stressed the importance of this approval. “For years, we have worked to ensure no one is limited by an HIV diagnosis just because of their age,” he said. This approval, he added, brings a new option for some of the youngest people with HIV.

The European Commission’s decision follows years of research. Data from the PAINT and PICTURE studies provided key evidence, confirming EDURANT®’s safety and effectiveness for pediatric patients.

The PAINT study has been collecting data for several years. It has tracked rilpivirine’s effects on younger patients. The more recent PICTURE study further confirmed the treatment’s benefits for children.

Both studies showed EDURANT®’s ability to maintain virological suppression in young patients. The medication worked in both treatment-experienced and new patients. Notably, the studies reported no new safety concerns.

This approval follows similar moves in other regions. The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency backed the approval in July 2024, and the U.S. FDA granted similar approval in March 2024.

These approvals mark a significant shift in pediatric HIV care. Both the EU and the U.S. now offer this treatment for young HIV patients. Access to EDURANT® across these regions brings hope to children and families.

This new approval benefits both healthcare providers and families. The 2.5 mg dispersible tablet allows for weight-based dosing, so children who struggle to swallow pills can take this form more easily.

According to the treatment guidelines, children weighing at least 14 kg can now receive body-weight-adjusted doses. It makes treatment more flexible and allows doctors to offer a more personalized approach for young patients.

Johnson & Johnson’s Janssen Research & Development team continues to work on advanced solutions. They hope this expanded use of EDURANT® will improve long-term outcomes for children with HIV. This approval, they believe, will enhance the lives of young patients and their families.

EDURANT® (rilpivirine) (NNRTI) reduces HIV-1 replication in the body. When combined with other antiretroviral treatments, EDURANT® helps control viral load.

Originally, EDURANT® 25 mg was intended for adults and children weighing at least 25 kg. Now, the new 2.5 mg tablet benefits smaller and younger patients. This new option broadens treatment possibilities for children.

Rilpivirine, the active component in EDURANT®, blocks HIV reverse transcriptase. This enzyme allows the virus to replicate. By inhibiting it, EDURANT® slows down HIV’s spread within the body.

The product labeling suggests doctors use genotypic resistance testing. It ensures the treatment matches the specific needs of each patient. With these guidelines, healthcare providers can offer the most effective care.

Historically, adult HIV treatments have developed faster than those for children. Pediatric patients have had fewer options specifically designed for their needs. This approval of EDURANT®’s 2.5 mg tablet addresses that gap in pediatric care.

Young patients with HIV face unique health challenges. The virus can affect their growth and development. Thus, treatment strategies must consider virus control and long-term health.

The new pediatric formulation of EDURANT® aligns with global healthcare goals. It supports a future where young people with HIV have equal treatment options. This approval brings hope for improved health outcomes for young patients.

Johnson & Johnson remains committed to global HIV care. It continuously pushes for advancements in prevention, management, and treatment. The company’s goal is a world where HIV is effectively managed and, one day, eradicated.

Around the world, pediatric HIV care has long needed accessible solutions. The European Commission’s approval of this treatment is an important step forward. It fills a need for younger, lower-weight children.

Healthcare providers, policymakers, and families view this decision as a positive development. The expanded access to EDURANT® brings hope for better healthcare. It provides a new option in the fight against pediatric HIV.

Johnson & Johnson has issued cautionary statements about future projections. They remain optimistic but acknowledge the challenges ahead. They continue to conduct research and refine EDURANT® for future needs.

Regulatory, cost, and policy issues are constant factors in healthcare innovation. Despite these challenges, Johnson & Johnson remains focused on improving patient outcomes. This latest expansion of EDURANT® reflects their commitment to inclusive healthcare.

As EDURANT® reaches more children in Europe, its impact will grow. Patients and families stand to benefit from this new option. Its expanded access offers a brighter future for young people living with HIV.

Scroll to Top