AbbVie’s MAVIRET approved in EU for acute HCV in patients aged 3+ with compensated liver disease, after Phase 3 trial showed 96.2% sustained virological response in 286 subjects. SKYRIZI secures EU approval for pediatric plaque psoriasis in children aged 6+, backed by OptIMMize trials using 55 mg pre-filled syringe for weight-based dosing.
AbbVie’s oral pangenotypic DAA MAVIRET (glecaprevir/pibrentasvir) is approved in the European Union for treating acute HCV infection in adults and children aged 3 years and older with compensated liver disease. The decision makes MAVIRET the only therapy authorized in the EU for both acute and chronic HCV, supported by the Phase 3 M20-350 trial in which 96.2% of 286 treatment-naïve subjects achieved sustained virological response 12 weeks post-treatment.
The European Commission also approved SKYRIZI (risankizumab) for children and adolescents aged 6 years and older with moderate to severe plaque psoriasis who are candidates for systemic therapy. The authorization is based on Phase 3 OptIMMize-1 and OptIMMize-2 trials evaluating a new 55 mg pre-filled syringe designed for weight-based dosing in patients weighing under 40 kg, demonstrating robust efficacy and safety profiles.
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