Johnson & Johnson announced that the European Commission (EC) has approved the expanded use of Edurant (rilpivirine) for HIV-1 treatment in younger patients.
This approval includes adults and children weighing at least 25kg without known non-nucleoside reverse transcriptase inhibitor (NNRTI) resistance mutations and with a viral load ≤ 100,000 copies/ml.
To support the approval, Johnson & Johnson has developed a new 2.5mg dispersible tablets. It is intended for weight-adjusted dosing in children aged two to under 18 years, weighing between 14kg and 25kg.
This approval follows the July 2024 positive opinion from the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) and the March 2024 US Food and Drug Administration (FDA) approval for select paediatric patients.
The EC decision was backed by Phase 2b PAINT and PICTURE studies, confirming no new safety concerns for rilpivirine.
The studies showed that Edurant achieves and maintains virological suppression in both treatment-experienced and treatment-naïve paediatric patients when used with other antiretroviral therapies.
Johnson & Johnson communicable diseases end-to-end development global head Brian Woodfall said: “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.”
In a separate development, Johnson & Johnson announced results from the Phase 3 GRAVITI study of Tremfya (guselkumab) for Crohn’s disease.
In the study, a higher number of patients receiving subcutaneous Tremfya induction and maintenance achieved clinical and endoscopic remission at 48 weeks compared to those on placebo.
If approved by the FDA, guselkumab could become the first IL-23 treatment to provide both subcutaneous and intravenous induction options for Crohn’s disease patients.
Tremfya received FDA approval in September 2024 for treating adults with moderately to severely active ulcerative colitis (UC).
Additionally, regulatory applications for the drug to treat adults with both UC and CD have been submitted in Europe.
