NORTH CHICAGO, Ill., March 14, 2017 /PRNewswire/ -- AbbVie (NYSE: ABBV), a global biopharmaceutical company, today 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.
*Patients with a sustained virologic response at 12 weeks post treatment (SVR12) are considered cured of hepatitis C.
About AbbVie's G/P Clinical Development Program
AbbVie's glecaprevir/pibrentasvir (G/P) global clinical development program was designed to investigate a faster path to virologic cure* for all major HCV genotypes (GT1-6) and with the goal of addressing treatment areas of continued unmet need. In Japan, AbbVie studied the G/P regimen in additional dedicated clinical trials due to patient and viral characteristics specific to the Japanese HCV patient population.
G/P is an investigational, pan-genotypic regimen that is being evaluated as a potential cure in 8 weeks for HCV patients without cirrhosis and who are new to treatment with direct-acting antivirals (DAA), who make up the majority of HCV patients. AbbVie is also studying G/P in patients with specific treatment challenges, such as genotype 3, patients who were not cured with previous DAA treatment and those with chronic kidney disease, including patients on dialysis.
G/P is an investigational, once-daily regimen that combines two distinct antiviral agents in a fixed-dose combination of glecaprevir (300mg), an NS3/4A protease inhibitor, and pibrentasvir (120mg), an NS5A inhibitor. G/P is dosed once-daily as three oral tablets.
Glecaprevir (GLE) was discovered during the ongoing collaboration between AbbVie and Enanta Pharmaceuticals (NASDAQ: ENTA) for HCV protease inhibitors and regimens that include protease inhibitors.
G/P is an investigational product and its safety and efficacy have not been established in Japan.
AbbVie is a global, research-based biopharmaceutical company formed in 2013 following separation from Abbott Laboratories. The company's mission is to use its expertise, dedicated people and unique approach to innovation to develop and market advanced therapies that address some of the world's most complex and serious diseases. Together with its wholly-owned subsidiary, Pharmacyclics, AbbVie employs approximately 29,000 people worldwide and markets medicines in more than 170 countries. For further information on the company and its people, portfolio and commitments, please visit www.abbvie.com. Follow @abbvie on Twitter or view careers on our Facebook or LinkedIn page.
Some statements in this news release may be forward-looking statements for purposes of the Private Securities Litigation Reform Act of 1995. The words "believe," "expect," "anticipate," "project" and similar expressions, among others, generally identify forward-looking statements. AbbVie cautions that these forward-looking statements are subject to risks and uncertainties that may cause actual results to differ materially from those indicated in the forward-looking statements. Such risks and uncertainties include, but are not limited to, challenges to intellectual property, competition from other products, difficulties inherent in the research and development process, adverse litigation or government action, and changes to laws and regulations applicable to our industry.
Additional information about the economic, competitive, governmental, technological and other factors that may affect AbbVie's operations is set forth in Item 1A, "Risk Factors," of AbbVie's 2015 Annual Report on Form 10-K, which has been filed with the Securities and Exchange Commission. AbbVie undertakes no obligation to release publicly any revisions to forward-looking statements as a result of subsequent events or developments, except as required by law.
1 Gower, E. Global epidemiology and genotype distribution of the hepatitis C virus infection. Journal of Hepatology 2014; 61: S45-S57. Table 2
2 National Center for Global Health and Medicine. Hepatitis C. Assessed January 2017. Available from: http://www.kanen.ncgm.go.jp/cont/010/c_gata.html