AbbVie, a global biopharmaceutical company, announced that priority review has been granted by the Japanese Ministry of Health, Labour and Welfare (MHLW) for its investigational, pan-genotypic, ribavirin-free regimen of glecaprevir/pibrentasvir (G/P) for the treatment of all major genotypes (GT1-6) of the chronic hepatitis C virus (HCV). This priority review follows European Medicines Agency (EMA) accelerated assessment and U.S. Food and Drug Administration (FDA) priority review designations in December 2016 and January 2017 respectively.
“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,” said Michael Severino, M.D., executive vice president, research and development and chief scientific officer, AbbVie. “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.”
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 genotypes 3-6 patients. 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 (direct-acting antiviral) treatment.
The New Drug Application (NDA) in Japan was supported by data from the Phase 3 CERTAIN studies in Japanese patients and supplemented with registrational studies in AbbVie’s G/P global clinical development program, which evaluated more than 2,300 patients in 27 countries across all major HCV genotypes and special populations. Patient populations studied included GT1-6, those new and experienced to treatment, those with compensated cirrhosis and without cirrhosis and patients with specific treatment challenges, including those with severe CKD, and those not cured with a prior DAA-containing regimen. The global program was designed to investigate a faster path to virologic cure* for all major HCV genotypes (GT1-6) and with the goal of addressing areas of continued unmet need.
In Japan, the NDA for the G/P regimen was submitted in February 2017.
Filed Under: Drug Discovery