AbbVie Gets European Commission Approval to Shorten Maviret Regimen
March 06 2020 - 7:43AM
Dow Jones News
By Chris Wack
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.
Write to Chris Wack at chris.wack@wsj.com
(END) Dow Jones Newswires
March 06, 2020 07:28 ET (12:28 GMT)
Copyright (c) 2020 Dow Jones & Company, Inc.
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