The regulatory update for Skyrizi allows the drug to be administered to patients aged six and older suffering from moderate to severe plaque psoriasis, provided they are candidates for systemic therapy. Previously, the treatment was restricted to the adult population. To accommodate this younger demographic, the North Chicago-based company is introducing a 55-milligram pre-filled syringe specifically designed for weight-based dosing in patients weighing less than 40 kilograms.
In section Market Quotes
European Regulators Expand Labels for AbbVie’s Skyrizi and Maviret
The European Commission has granted expanded marketing authorizations for two of AbbVie’s key therapeutic assets, lowering the age threshold for Skyrizi in psoriasis patients and broadening the scope of the hepatitis C treatment Maviret to include acute infections in children as young as three years old.
In a separate decision, the commission authorized Maviret for the treatment of acute hepatitis C virus infections. This approval extends the drug’s utility to pediatric patients starting at age three. According to the company, Maviret now stands as the only therapeutic option within the European Union indicated for both acute and chronic forms of the hepatitis C virus.
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