AbbVie Wins EU Approval to Expand Skyrizi and Maviret to Pediatric Patients
AbbVie announced European Commission approvals extending Skyrizi to children with moderate to severe plaque psoriasis and making Maviret the only EU-cleared therapy for both acute and chronic hepatitis C from age three. These label expansions broaden AbbVie's reach in immunology and virology.
AbbVie (ABBV) reported this week that the European Commission approved label expansions for Skyrizi (risankizumab) to treat pediatric patients with moderate to severe plaque psoriasis, and for Maviret (glecaprevir/pibrentasvir) as the only therapy cleared in the EU for both acute and chronic hepatitis C infection in children aged three and older. The approvals open earlier treatment windows and add pediatric populations in high-need diseases.
The Products
Skyrizi is a biologic targeting IL-23 for plaque psoriasis. Maviret is a direct-acting antiviral for hepatitis C.
Pricing and Availability
AbbVie has not disclosed pricing details. Availability in EU markets is expected in the coming months following local regulatory procedures.
Competition
In pediatric psoriasis, Skyrizi competes with Johnson & Johnson's Stelara and Novartis' Cosentyx. For hepatitis C, Maviret faces competition from Gilead's Epclusa but is the only option approved for both acute and chronic pediatric infection.
Potential Impact on AbbVie
The expansions could help offset Humira's patent loss by boosting Skyrizi sales and solidify Maviret's niche in hepatitis C, though the market size is relatively limited.
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