AbbVie Demonstrates Leadership in HCV with New MAVYRET™ (glecaprevir/pibrentasvir) Data to be Presented at The Liver Meeting® 2017

NORTH CHICAGO, Ill., Oct. 11, 2017 /PRNewswire/ -- AbbVie (NYSE: ABBV), a global research and development based biopharmaceutical company, today announced that it will present new data evaluating MAVYRET™ (glecaprevir/pibrentasvir), its once-daily, ribavirin-free treatment for adults with chronic hepatitis C virus (HCV) infection across all major genotypes (GT1-6), at the annual meeting of the American Association for the Study of Liver Diseases (AASLD). Sixteen AbbVie scientific abstracts have been accepted, including two oral presentations studying the use of MAVYRET in patients across genotypes (GT1-6) with compensated cirrhosis and treatment-naïve patients with genotype 3 (GT3) HCV. These populations have historically had limited treatment options. A third oral presentation evaluates adherence to treatment with MAVYRET in the clinical development program. The Liver Meeting® 2017 will take place in Washington, D.C., from October 20 – 24, 2017.

AbbVie Announces Approval of MAVIRET™ (glecaprevir/pibrentasvir) for the Treatment of Chronic Hepatitis C in All Major Genotypes (GT1-6) in Japan

NORTH CHICAGO, Ill., Sept. 27, 2017 /PRNewswire/ -- AbbVie (NYSE: ABBV), a global research and development-based biopharmaceutical company, today announced that the Japanese Ministry of Health, Labour and Welfare (MHLW) approved MAVIRET™ (glecaprevir/pibrentasvir), a once-daily, ribavirin-free treatment for adults with chronic hepatitis C virus (HCV) infection across all major genotypes (GT1-6). MAVIRET is the first and only 8-week treatment option in Japan for GT1 and GT2 HCV infected patients without cirrhosis and who are new to direct-acting antiviral (DAA) treatment,* including those with chronic kidney disease (CKD). These patients represent the majority of people living with HCV in Japan.2  

AbbVie Receives U.S. FDA Approval of MAVYRET™ (glecaprevir/pibrentasvir) for the Treatment of Chronic Hepatitis C in All Major Genotypes (GT 1-6) in as Short as 8 Weeks

NORTH CHICAGO, Ill., Aug. 3, 2017 /PRNewswire/ -- AbbVie (NYSE: ABBV), a global biopharmaceutical company, today announced that the U.S. Food and Drug Administration (FDA) approved MAVYRET™ (glecaprevir/pibrentasvir), a once-daily, ribavirin-free treatment for adults with chronic hepatitis C virus (HCV) infection across all major genotypes (GT1-6). MAVYRET is an 8-week, pan-genotypic treatment for patients without cirrhosis and who are new to treatment. Up to 95 percent of HCV patients in the U.S. may be eligible for treatment with MAVYRET, including patients with compensated cirrhosis or without cirrhosis and those with limited treatment options, such as patients with chronic kidney disease (CKD).*

European Commission Grants AbbVie's MAVIRET® (glecaprevir/pibrentasvir) Marketing Authorization for the Treatment of Chronic Hepatitis C in All Major Genotypes (GT1-6)

NORTH CHICAGO, Ill., July 28, 2017 /PRNewswire/ -- AbbVie (NYSE: ABBV), a global biopharmaceutical company, today announced that the European Commission has granted marketing authorization for MAVIRET® (glecaprevir/pibrentasvir), a once-daily, ribavirin-free treatment for adults with chronic hepatitis C virus (HCV) infection across all major genotypes (GT1-6). MAVIRET is a new 8-week, pan-genotypic treatment for patients without cirrhosis and who are new to treatment,* who comprise the majority of the 71 million people living with HCV globally.2,3

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Eight Weeks of Treatment with AbbVie's Investigational, Pan-Genotypic Regimen of Glecaprevir/Pibrentasvir (G/P) Achieved High SVR(12) Rates in Challenging to Treat Genotype 3 Chronic Hepatitis C

AMSTERDAM, April 21, 2017 /PRNewswire/ -- AbbVie (NYSE: ABBV), a global biopharmaceutical company, today announced high SVR12 rates were achieved with 8 weeks of treatment with its investigational, once-daily, ribavirin-free, pan-genotypic regimen of glecaprevir/pibrentasvir (G/P) in patients with challenging to treat genotype 3 (GT3) chronic hepatitis C virus (HCV) infection. In results from the Phase 3 ENDURANCE-3 study, 95 percent (n=149/157) of GT3 chronic HCV infected patients without cirrhosis and who are new to treatment achieved sustained virologic response at 12 weeks post-treatment (SVR12) following 8 weeks of treatment with G/P.1 These new data will be featured as an oral presentation today at The International Liver Congress™ (ILC) 2017 in Amsterdam, The Netherlands.

AbbVie's Investigational, Pan-Genotypic, Ribavirin-free Regimen of Glecaprevir/Pibrentasvir (G/P) Achieved 99 Percent SVR(12) Rate in Chronic Hepatitis C Patients with Compensated Cirrhosis

AMSTERDAM, April 20, 2017 /PRNewswire/ -- AbbVie (NYSE: ABBV), a global biopharmaceutical company, today announced that 99 percent (n=145/146) of chronic hepatitis C virus (HCV) infected patients with genotype 1, 2, 4, 5 or 6 and compensated cirrhosis (Child-Pugh A) achieved sustained virologic response at 12 weeks post-treatment (SVR12) with its investigational, pan-genotypic regimen of glecaprevir/pibrentasvir (G/P). These high SVR12 rates were seen following 12 weeks of G/P treatment without ribavirin. Patients with specific virus strains associated with resistance or with a high quantity of the virus in their bloodstream before treatment initiation were not excluded from the study. These new data, from the Phase 3 EXPEDITION-1 study, will be featured as an oral presentation today at The International Liver Congress™ (ILC) 2017 in Amsterdam, The Netherlands.

AbbVie Granted Priority Review in Japan for its Investigational Regimen of Glecaprevir/Pibrentasvir (G/P) for the Treatment of All Major Genotypes of Chronic Hepatitis C

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.

AbbVie Receives CHMP Positive Opinion for Eight-Week Treatment Option with VIEKIRAX® (ombitasvir/paritaprevir/ritonavir tablets) + EXVIERA® (dasabuvir tablets) for Patients with Genotype 1b Chronic Hepatitis C

NORTH CHICAGO, Ill., Feb. 27, 2017 /PRNewswire/ -- AbbVie (NYSE: ABBV), a global biopharmaceutical company, announced today that the European Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has granted a positive opinion for a shorter, eight-week treatment of VIEKIRAX® (ombitasvir/paritaprevir/ritonavir tablets) + EXVIERA® (dasabuvir tablets) as an option for previously untreated adult patients with genotype 1b (GT1b) chronic hepatitis C virus (HCV) and minimal to moderate fibrosis*.

U.S. FDA Grants Priority Review to AbbVie for its Investigational Regimen of Glecaprevir/Pibrentasvir (G/P) for the Treatment of Chronic Hepatitis C in All Major Genotypes (GT1-6)

NORTH CHICAGO, Ill., Feb. 2, 2017 /PRNewswire/ -- AbbVie (NYSE: ABBV), a global biopharmaceutical company, today announced that the U.S. Food and Drug Administration (FDA) has accepted its New Drug Application (NDA) and granted priority review for its investigational, pan-genotypic regimen of glecaprevir/pibrentasvir (G/P), being evaluated for the treatment of all major genotypes (GT1-6) of chronic hepatitis C virus (HCV). The FDA grants priority review designation to medicines that it determines have the potential to provide significant improvements in the safety and effectiveness of the treatment of a serious disease. The NDA is supported by data from eight registrational studies in AbbVie's G/P clinical development program, which evaluated more than 2,300 patients in 27 countries across all major HCV genotypes and for special populations.