Clinical-stage biotechnology company Enanta Pharmaceuticals Inc (NASDAQ:ENTA) announced on Tuesday that its partner AbbVie (NYSE:ABBV) has received European Commission approval for MAVIRET (glecaprevir/pibrentasvir) to treat acute hepatitis C virus (HCV) infection in adults and children aged three years and older with or without compensated cirrhosis.
This approval makes MAVIRET, an oral pangenotypic direct-acting antiviral (DAA) therapy, the only treatment authorised in the European Union for both acute and chronic HCV infection.
The decision was supported by a Phase 3 multicentre, single-arm prospective study evaluating an eight-week treatment regimen, which demonstrated high efficacy in patients with acute hepatitis C virus infection. Most reported adverse events were mild or moderate, with fatigue, diarrhoea, headache and asthenia identified as the most common.
Enanta said that early diagnosis and treatment can reduce transmission, lower the risk of long-term liver-related complications and support hepatitis C elimination efforts.
Glecaprevir, one of the two direct-acting antivirals in MAVIRET, was discovered by Enanta and developed and commercialised by AbbVie, with the therapy marketed as MAVYRET in the US and MAVIRET outside the US.
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