Japan to review drug for the treatment of chronic hepatitis C
"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," Dr. Michael Severino, AbbVie's executive vice president and chief scientific officer, said in a press release. "We are pleased that G/P has now been recognized as a potential important therapy for people living with HCV through the receipt of priority review designations by regulatory authorities in Japan, the EU and the U.S."
Japan has one of the highest rates of hepatitis C infection in the industrialized world, with approximately 1 million people living with the disease, according to the release.
Japan designates priority review to certain medicines based on the clinical usefulness of the treatment and severity of the disease.
If approved, Glecaprevir/Pibrentasvir may provide a short, eight week, cure for the majority of people living with hepatitis C in Japan, the release said.
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