US-based pharmaceutical company AbbVie (NYSE:ABBV) announced on Wednesday that the US Food and Drug Administration (FDA) has approved a label expansion for MAVYRET (glecaprevir/pibrentasvir), an oral pangenotypic direct acting antiviral (DAA) therapy.

It is now approved for the treatment of adults and paediatric patients aged three years and older with acute or chronic hepatitis C virus (HCV) infection without cirrhosis or with compensated cirrhosis. The company says that with this approval, MAVYRET is the first and only DAA therapy approved to treat patients with acute HCV in eight weeks with a 96% cure rate.

Providers can now treat HCV patients with MAVYRET immediately at the time of diagnosis.

The FDA granted Breakthrough Therapy Designation (BTD) for MAVYRET for the treatment of acute HCV. This programme is designed to expedite the development and review of medicines that are intended to treat a serious condition. Preliminary clinical evidence indicates that the drug may demonstrate substantial improvement over existing therapies on one or more clinically significant endpoints, AbbVie said.

The label expansion was supported by data from the Phase 3, multicentre, single-arm prospective study evaluating the safety and efficacy of MAVYRET eight-week treatment in adults with acute HCV infection. The study results showed MAVYRET to be a highly efficacious treatment for people with acute HCV. The majority of the adverse events reported were mild or moderate in severity. The most common adverse events were fatigue, asthenia, headache, and diarrhoea.