Johnson & Johnson’s Edurant Receives the EC Approval for Expanded Use as HIV-1 Therapy in Pediatric Individuals
Shots:
- The expanded approval of Edurant for pediatric use now includes new 2.5mg dispersible tablets, specifically designed for weight-adjusted dosing in children aged 2-18yrs. (weighing between 14-25kg)
- This approval was supported by P-IIb (PAINT & PICTURE) trials that demonstrated Edurant safety, efficacy, and effectiveness in achieving virological suppression in pediatric individuals, received CHMP positive opinion in July’24 and also received approval from FDA in Jul'24 for same population
- Edurant oral drug used for HIV‑1 infected individuals without known mutations associated with resistance to the non-nucleoside reverse transcriptase inhibitor class, and with a viral load ≤ 100,000 HIV‑1 RNA copies/ml
Ref: Johnson & Johnson | Image: Johnson & Johnson
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