The US Food and Drug Administration (FDA) has approved the label expansion of AbbVie’s Mavyret (glecaprevir/pibrentasvir) for treating adults and paediatric patients three years and older with acute or chronic hepatitis C virus (HCV) infection.
The extended indication for this oral pangenotypic direct-acting antiviral (DAA) therapy involves those who have the infection without cirrhosis or with compensated cirrhosis.
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The therapy is the first and only DAA treatment approved for this patient group.
HCV is a blood-borne infectious disease that can lead to serious liver complications.
The agency’s approval is based on data from a Phase III, single-arm, prospective multicentre trial that evaluated the efficacy and safety of an eight-week treatment of the therapy in adults with acute HCV infection.
Findings from the trial demonstrated that the therapy is a highly efficacious treatment option.
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By GlobalDataAbbVie research and development executive vice-president and chief scientific officer Roopal Thakkar stated: “Mavyret has treated more than one million patients with HCV, but we recognise that a significant need remains for patients with acute infection.
“The label expansion for Mavyret, coupled with the implementation of ‘test and treat’ models of care, serves as a tool to support the public health community in treating more patients and bringing us closer to achieving the global 2030 elimination goal.”
Mavyret had also secured a breakthrough therapy designation from the US regulator for acute HCV.
This status expedites the development and review of medicines intended to treat serious conditions when preliminary clinical evidence suggests substantial improvement over current therapies.
In May 2025, AbbVie signed a partnership and licensing agreement with US-based ADARx Pharmaceuticals, committing $335m upfront to access its small interfering RNA platform.
