Japan’s MHLW grants priority review for AbbVie’s chronic HCV treatment
The Japanese Ministry of Health, Labour and Welfare (MHLW) has granted priority review for US-based biopharmaceutical company AbbVie’s glecaprevir / pibrentasvir (G / P) cure to treat all major genotypes (GT1-6) of the chronic hepatitis C virus (HCV).
G / P is an investigational, pan-genotypic, ribavirin-free treatment that can be administered once daily to a patient affected with chronic HCV.
AbbVie executive vice-president, research and development and chief scientific officer Dr Michael Severino said: “We will work closely with the Japanese Pharmaceuticals and Medical Devices Agency (PMDA) as part of our commitment to provide a potential cure for as many people living with HCV as possible.
“We are pleased that G/P has now been recognised as a potential important therapy for people living with HCV through the receipt of priority review designations by regulatory authorities in Japan, the European Union (EU) and the US.”
AbbVie’s G/P, if approved, is expected to offer a shorter treatment with duration of eight weeks for patients affected with GT1 and GT2 HCV without cirrhosis, and an additional treatment option for patients with GT3 to GT6.
The cure can also be used to meet the requirements of patients with specific treatment challenges, such as the ones with severe chronic kidney disease (CKD) and those who are not cured with a previous direct-acting anti-viral (DAA).
AbbVie was granted the European Medicines Agency (EMA) accelerated assessment in December last year, and the US Food and Drug Administration (FDA) priority review designations in January this year.
Image: Electron micrographs of hepatitis C virus purified from cell culture. Photo: courtesy of the Center for the Study of Hepatitis C, The Rockefeller University / Charles Rice.