NAN August 2017

28 NORTH AMERICA NEWS / August 2017 , AbbVie, a global biopharmaceutical company, on August 3rd announced that the U.S. Food and Drug Administration (FDA) approvedMAVYRET™ (glecaprevir/pibrentasvir), a once-daily, ribavirin-free treatment for adults with chronic hepatitis C virus (HCV) infection across all major genotypes (GT1-6). AbbVie Receives U.S. FDA Approval of MAVYRET ™ MAVYRET is an eight-week, pan- genotypic treatment for patients without cirrhosis and who are new to treatment. Up to 95% 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). * “With MAVYRET, physicians and patients now have a treatment option that is highly effective and has the potential to cure most HCV patients in as short as eight weeks, regardless of genotype,” said Michael Severino, M.D., executive vice president, research and development and chief scientific officer, AbbVie. “The approval of MAVYRET demonstrates AbbVie’s commitment to advancing science to help address unmet needs by delivering a new cure for patients who historically had limited treatment options, including those with genotype 3 HCV, individuals with CKD and certain DAA failure patients.” Approximately 3.4 million Americans are chronically infected with HCV.1 Additionally, HCV is common among people with severe CKD, with an estimated more than 500,000ⱡ people having both chronic HCV and CKD.2 MAVYRET was designed to deliver a cure** across all major genotypes and specific treatment challenges, such as patients with severe CKD, and GT1 patients not cured by a NS5A inhibitor or a NS3/4A protease inhibitor (PI) direct- acting antiviral (DAA) treatment, but not both. MAVYRET combines two new DAAs that target and inhibit proteins essential for the replication of the hepatitis C virus. “The clinical trial program for MAVYRET resulted in high cure rates across a range of patient populations, from those who have never been treated and who do not have cirrhosis, all the way to patients with compensated cirrhosis,” said Fred Poordad, M.D., vice president, academic and clinical affairs, Texas Liver Institute and professor of medicine, University of Texas Health, San Antonio. “This approval helps achieve physicians’ goals of delivering effective options for a broad range of patients.” The approval of MAVYRET is supported by data from nine registrational studies in AbbVie’s clinical development program, which evaluated more than 2,300 patients in 27 countries across all major HCV genotypes (GT1-6) and special populations. Approval of MAVYRET follows an FDA-granted breakthrough therapy designation for the treatment of GT1 HCV patients who were not cured with prior DAA therapy, as well as priority review. According to the FDA, breakthrough therapy designation is intended to expedite the development and review of therapies for serious or life-threatening conditions, which may offer substantial improvement over available therapies. AbbVie’s pan-genotypic regimen was also recently granted marketing authorization by the European Commission. AbbVie’s treatment is now licensed for use in all 28 member states of the European Union, as well as Iceland, Liechtenstein and Norway. * Ipsos Healthcare HCV Monitor, 2017. New York, NY: Ipsos in North America. © Ipsos 2017, all rights reserved. * Patients who achieve a sustained virologic response at 12 weeks’ post treatment (SVR12) are considered cured of hepatitis C. ⱡBased on IMS Dx (Oct. 2016) distribution of 15.7% Renal patients in diagnosed population applied to ~3.4M HCV prevalence population of all major HCV genotypes. About MAVYRET™ (glecaprevir/pibrentasvir) MAVYRET™ is approved by the U.S. Food and Drug Administration (FDA) for the treatment of chronic hepatitis C virus (HCV) infection in adults across all major genotypes (GT1-6). MAVYRET is a pan- genotypic, once-daily, ribavirin- free treatment that combines glecaprevir (100mg), an NS3/4A protease inhibitor, and pibrentasvir (40mg), an NS5A inhibitor, dosed once-daily as three oral tablets, taken with food.