WATERTOWN, Mass.–(BUSINESS WIRE)–
Enanta Pharmaceuticals, Inc. (ENTA), a research and development-focused biotechnology company dedicated to creating small molecule drugs for viral infections and liver diseases, today announced that priority review has been granted by the Japanese Ministry of Health, Labour and Welfare (MHLW) to AbbVie for its investigational, pan-genotypic, ribavirin-free combination of glecaprevir/pibrentasvir (G/P) for the treatment of all major genotypes (GT1-6) of chronic hepatitis C virus (HCV) infection. The NDA for the G/P regimen in Japan was submitted in February 2017.
“Receiving priority review in the U.S., the E.U. and now Japan validates that there is continued unmet need for patients with HCV around the world,” commented Jay R. Luly, Ph.D., President and Chief Executive Officer, Enanta. “If G/P is approved, we look forward to this important treatment option being available to the estimated 1 million people in Japan living with HCV.”
The Japanese MHLW designates priority review to certain medicines based on the clinical usefulness of the treatment and severity of the disease. Japan has one of the highest rates of hepatitis C infection in the industrialized world, with approximately 1 million people living with the disease, 99 percent of whom are infected with genotype 1 (GT1) or genotype 2 (GT2).1,2 If approved, G/P may provide a shorter, eight-week treatment duration for GT1 and GT2 patients without cirrhosis, who make up the majority of HCV patients, and an additional treatment option for patients with any of genotypes 3-6. G/P is also intended to address the needs of patients with specific treatment challenges, including those with severe chronic kidney disease (CKD) and those not cured with previous DAA treatment.
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