AbbVie’s hepatitis C treatment under accelerated review by EMA

The investigational regimen of Glecaprevir/Pibrentasvir (G/P), which is now under accelerated assessment by EMA, is used as treatment for patients affected with genotypes 1-6 of the hepatitis C virus.

If approved, G/P could offer a shorter, eight week, once-daily, ribavirin-free treatment option for the majority of HCV patients without cirrhosis.

AbbVie's MAA is supported by data from global registrational clinical development program across all major HCV genotypes and in patients with specific treatment challenges.

AbbVie executive vice president, research and development and chief scientific officer Michael Severino said: “We will work closely with the EMA as we continue our commitment to potentially provide a cure for as many people living with HCV as possible.

"We believe G/P has the potential to further impact the HCV treatment landscape, shortening the treatment duration to just eight weeks for the majority of people living with chronic HCV without cirrhosis."

Once approved, the G/P regimen is expected be available for marketing in the European Union in the second half of this year.

The regimen is being assessed as a potential cure in eight weeks for HCV patients without cirrhosis and who are new to treatment with direct-acting antivirals (DAA).

AbbVie is also evaluating G/P in patients with specific treatment challenges, like genotype 3, patients who were not cured with earlier DAA treatment and those with CKD, including patients on dialysis.

G/P is a fixed-dose combination of glecaprevir (300mg), an NS3/4A protease inhibitor, and pibrentasvir (120mg), an NS5A inhibitor, dosed once-daily as three oral tablets.

Image: AbbVie Corporate Headquarters. Photo: courtesy of AbbVie Inc.