AbbVie receives priority review for new 8-week DAA in Japan

The Japanese Ministry of Health, Labour and Welfare has granted priority review to AbbVie’s direct-acting antiviral glecaprevir/pibrentasvir for the treatment of all major genotypes of chronic hepatitis C, according to a press release.

Glecaprevir/pibrentasvir (G/P) is an investigational ribavirin-free regimen under evaluation as a potential 8-week cure for patients with HCV genotypes 1 through 6 with cirrhosis who are new to treatment with DAAs.

G/P is also under evaluation for treatment of patients with special conditions, such as patients with genotype 3 who were not cured with previous DAA treatment and patients with chronic kidney disease, including those on dialysis.

To date, AbbVie’s G/P global clinical development program combined with its phase 3 CERTAIN studies in Japan have evaluated more than 2,300 patients in 27 countries with major HCV genotypes and special conditions.

“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,” Michael Severino, MD, executive vice president of research and development and chief scientific officer of AbbVie, said in the 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.”

Reference: www.abbvie.com