European Commission Approves Expanded Use of Edurant for Younger Pediatric HIV-1 Patients
核心洞察
The European Commission (EC) has approved the expanded use of Edurant (rilpivirine) for treating HIV-1 (搜索) in younger patients, including children weighing at least 25kg.
Johnson & Johnson developed a new 2.5mg dispersible tablet for weight-adjusted dosing in children aged two to under 18 years, weighing between 14kg and 25kg.
The approval is backed by Phase 2b PAINT and PICTURE studies, which confirmed the drug's safety and efficacy in achieving virological suppression in pediatric patients.
The European Commission (EC) has granted approval for the expanded use of Edurant (rilpivirine) in the treatment of HIV-1 (搜索) for younger patients. This decision allows for the use of rilpivirine in adults and children weighing at least 25kg, who do not have known non-nucleoside reverse transcriptase inhibitor (NNRTI) resistance mutations and maintain a viral load of ≤ 100,000 copies/ml.
To facilitate this expanded use, Johnson & Johnson has developed a new 2.5mg dispersible tablet. This formulation is specifically designed for weight-adjusted dosing in children aged two to under 18 years, weighing between 14kg and 25kg.
This approval follows a positive opinion from the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) in July 2024, and aligns with the US Food and Drug Administration (FDA) approval in March 2024 for select pediatric patients.
The EC's decision is supported by data from the Phase 2b PAINT and PICTURE studies. These studies confirmed the safety profile of rilpivirine and demonstrated its effectiveness in achieving and maintaining virological suppression in both treatment-experienced and treatment-naïve pediatric patients when used in conjunction with other antiretroviral therapies.
Brian Woodfall, Global Head of Communicable Diseases End-to-End Development at Johnson & Johnson, stated, “For years, we have worked to safeguard a future where no one is limited by an HIV diagnosis just because of their age. This approval will help ensure that some of the youngest people living with HIV have another treatment option that can work for them.”
Johnson & Johnson's Tremfya Shows Promise in Crohn's Disease
In a separate announcement, Johnson & Johnson shared results from the Phase 3 GRAVITI study, which evaluated Tremfya (guselkumab) for the treatment of Crohn’s disease (搜索). The study indicated that a higher proportion of patients receiving subcutaneous Tremfya induction and maintenance achieved both clinical and endoscopic remission at 48 weeks, compared to those receiving a placebo.
If approved by the FDA, guselkumab has the potential to become the first IL-23 (搜索) treatment offering both subcutaneous and intravenous induction options for patients with Crohn’s disease (搜索). Tremfya received FDA approval in September 2024 for treating adults with moderately to severely active ulcerative colitis (搜索) (UC). Regulatory applications for the drug to treat adults with both UC and CD have also been submitted in Europe.