AbbVie Secures CHMP Positive Opinion for MAVIRET Acute HCV Indication in EU Adults and Children

A label expansion for MAVIRET® (glecaprevir/pibrentasvir) is now one European Commission decision away, following the EMA's CHMP positive opinion recommending approval for acute hepatitis C virus (HCV) infection in adults and children aged 3 years and older. AbbVie anticipates the formal EC decision in Q3 2026, at which point MAVIRET's EU label would cover both acute and chronic HCV, a consolidated indication that carries direct consequences for batch release documentation, labelling artwork updates, and post-approval change management under existing GMP frameworks.

The opinion is supported by data from the Phase 3 M20-350 study, a multicenter, single-arm prospective trial evaluating an eight-week MAVIRET regimen in adults with acute HCV infection. The study reported a 96% cure rate measured by sustained virologic response at 12 weeks post-treatment (SVR12), with a safety profile consistent with prior chronic-indication experience; the most common adverse events were fatigue, diarrhea, headache, and asthenia. The paediatric scope, children aged 3 years and older, is carried forward from the existing chronic HCV approval, meaning formulation and dosing documentation for that population will require alignment with the expanded indication language.

For regulatory affairs leads managing the EU dossier, the transition from a single chronic indication to a dual acute/chronic label triggers a Type II variation pathway review and will require updated product information across all EU member states. QA directors should anticipate corresponding updates to batch release specifications and any indication-specific labelling controls embedded in current site master files. MAVIRET already holds acute and chronic HCV approval in the United States (as MAVYRET®), Canada, Australia, and several other markets, providing a reference framework for the EU variation package.

The clinical context reinforces the regulatory urgency: the 2026 WHO Global Hepatitis Report identifies diagnosis and treatment coverage as persistently below global elimination targets, and acute HCV's frequently asymptomatic presentation means patients are often identified incidentally and at risk of being lost to follow-up before treatment begins. A consolidated EU label removes a gap that has complicated care pathway standardisation across member states.

The EC decision in Q3 2026 will set the compliance clock for labelling implementation timelines across AbbVie's EU distribution network and any contract manufacturing organisations operating under the existing MAVIRET marketing authorisation.

Source: AbbVie News Center via PR Newswire, 22 May 2026.