AbbVie receives EC grant to market HCV treatment Maviret

The European Commission (EC) has granted marketing authorisation for AbbVie’s Maviret (glecaprevir / pibrentasvir) to treat adult patients with chronic hepatitis C virus (HCV) infection across all major genotypes (GT1-6).

MAVIRET is a new eight-week, pan-genotypic treatment for patients without cirrhosis and who are new to treatment, comprising the majority of the 71 million people living with HCV worldwide.

The once-daily, ribavirin-free therapy combines 100mg of glecaprevir, an NS3/4A protease inhibitor, and pibrentasvir at 40mg, an NS5A inhibitor, dosed once-daily as three oral tablets.

AbbVie chief scientific officer and research and development executive vice-president Dr Michael Severino said: "Maviret represents an innovation in HCV care as an eight-week, pan-genotypic option that combines two distinct antiviral agents and has high efficacy even against most genotypes commonly associated with resistance to treatment.

"This new treatment advancement has the potential to meet the diverse needs of patients in as short as eight weeks across Europe."

In addition, the treatment is indicated for patients with specific treatment challenges, including the ones with compensated cirrhosis across all major genotypes, and those who previously had limited treatment options, such as patients with severe chronic kidney disease (CKD) or those with genotype 3 (GT3) chronic HCV infection.

The EC approval is supported by data from eight registrational studies in the company’s clinical development programme, which assessed more than 2,300 patients in 27 countries across all major HCV genotypes and special populations.

The AbbVie therapy combines two new, potent, direct-acting antivirals that target and inhibit proteins essential for the replication of the HCV.

Glecaprevir (GLE) was discovered during the ongoing partnership between AbbVie and Enanta Pharmaceuticals for HCV protease inhibitors and regimens that include protease inhibitors.