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Friday, March 6, 2020

AbbVie Gets European Commission Approval to Shorten Maviret Regimen

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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