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AbbVie: Health Canada Approves Label Extension For MAVIRET To Include Use In Paediatric Patients

AbbVie (ABBV) announced Health Canada has approved a change in the marketing authorization for MAVIRET to include its use for the treatment in paediatric patients 3 to 12 years old, weighing at least 12kg to less than 45kg. It is now approved as an 8-week, pan-genotypic treatment for treatment-naïve, chronic HCV patients, without cirrhosis or with compensated cirrhosis in adults and children aged 3 years and older.

The company said the label extension is supported by data from the phase 2/3, non-randomized, open-label, multicenter DORA part 2 study evaluating the safety and efficacy of weight-based dosing of glecaprevir/pibrentasvir granules for 8, 12 or 16 weeks in 80 children aged 3 years to less than 12 years with chronic HCV infection.

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