AbbVie Inc. said Friday the European Commission has approved a change
to the marketing authorization for Maviret glecaprevir/pibrentasvir to
shorten once-daily treatment duration to eight weeks from in
treatment-naive, compensated cirrhotic, chronic hepatitis C patients
with genotype 3 infection.
Maviret was already indicated as an eight-week, pan-genotypic,
once-daily regimen for treatment-naive HCV patients without cirrhosis,
and as an eight-week, once-daily regimen for treatment-naive GT 1, 2, 4,
5 and 6 HCV patients with compensated cirrhosis.
AbbVie said the EC approval is supported by data from the Phase 3b
study, which evaluated safety and efficacy of Maviret in treatment-naive
chronic HCV patients with compensated cirrhosis across all major
genotypes.
To date, one virologic failure has been reported and no patients have discontinued treatment due to adverse events.
https://www.marketscreener.com/ABBVIE-INC-12136589/news/AbbVie-Gets-European-Commission-Approval-to-Shorten-Maviret-Regimen-30119769/
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