The Japanese Ministry of Health, Labour and Welfare (MHLW) has approved AbbVie’s Maviret (glecaprevir / pibrentasvir) to treat adults with chronic hepatitis C virus (HCV) infection across genotypes 1 to 6 (GT1-6).
The pan-genotypic, once-daily, ribavirin-free therapy is currently the first and only eight-week treatment option available in Japan for GT1 and GT2 HCV infected patients without cirrhosis and who are new to direct-acting antiviral (DAA) treatment, including those with chronic kidney disease (CKD).
In Japan, Maviret is also available for use for 12 weeks in patients infected with GT3-6, patients with specific treatment challenges, including those with compensated cirrhosis, and those with limited treatment options who were not cured with previous direct-acting antiviral (DAA) drug treatment.
AbbVie chief scientific officer and research and development executive vice-president Michael Severino said: “The human, social and economic burden of HCV to individuals in Japan can be significant as the disease progresses to the later stages.
“AbbVie is committed to working with health authorities to get Maviret to physicians and patients as quickly as possible, so that the opportunity for virologic cure in as short as eight weeks may be a reality for the majority of people living with HCV.”
The current approval is supported by data from the Phase III CERTAIN studies in Japanese patients and supplemented with registrational studies from the company’s global clinical development programme for Maviret.
The therapy combines two new and potent DAAs that target and inhibit proteins essential for the replication of HCV.
The approval follows priority review granted by the Japanese MHLW to certain medicines based on the clinical usefulness of the treatment and severity of the disease.