AbbVie said Thursday that its G/P (glecaprevir/pibrentasivr) treatment, showing a 99 percent cure rate for chronic hepatitis C, has gained approval in Japan.
The approval follows a priority review granted in the country in May. European authorities approved the drug for sale while American regulatory bodies approved the treatment for patients without cirrhosis and no previous treatment.
The approval is based on certain phase 3 trial results conducted in Japan and supplemental global studies, which evaluated more than 2,300 patients in 27 countries across chronic hepatitis C virus (HCV) types. The global EXPEDITION-1 study showed 99 percent (145 out of 146 people) of HCV patients with genotypes 1, 2, 4, 5 or 6 and compensated cirrhosis showed no evidence of the infection in their blood 12 weeks after receiving treatment
Japanese patients with type 1 or 2 of the disease without cirrhosis will now be able to benefit from the shorter, eight-week, once-daily, ribavirin-free cure. G/P is a combination of two new DAA agents that target and inhibit proteins that contribute to the replication of the hep C virus.
Japan has one of the highest hepatitis C infection and liver cancer rates among developed countries with around two million patients, according to AbbVie. Chronic hepatitis C is also one of the leading causes of liver cancer, the company said.
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