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Health Canada Grants Priority Review to AbbVie's Investigational Regimen of If approved, G/P may provide a shorter, eight week, once daily, ribavirin free treatment option for the majority of HCV patients without cirrhosis AbbVie's New Drug Submission is supported by data from its global registrational clinical development program across all major HCV genotypes and in patients with specific treatment challenges MONTREAL, Feb.
1, 2017 /CNW/ AbbVie, a global biopharmaceutical company, today announced it has submitted a New Drug Submission (NDS), and received priority review from Health Canada, for its investigational, pan genotypic regimen of glecaprevir (ABT 493)/pibrentasvir (ABT 530) (G/P) for the treatment of all major chronic hepatitis C virus (HCV) genotypes. If approved, G/P may provide a shorter treatment duration for genotypes 1 6 (GT1 6) in patients without cirrhosis, who make up a large portion of HCV patients in Canada, and an additional treatment option to patients with compensated cirrhosis (Child Pugh A). G/P is also intended to address the unmet medical needs of patients with specific treatment challenges, including those with severe chronic kidney disease (CKD) and those not cured with previous direct acting antiviral (DAA) treatment. "HCV patients with severe chronic kidney disease present a complex challenge for physicians to treat. This is particularly true in those with genotype 2 and 3 infection, and those with cirrhosis," said Dr. Curtis Cooper, Director of the Regional Hepatitis Program at the Ottawa Hospital. "Recent clinical trial results are louis vuitton alma fuchsia a positive development in AbbVie's investigation of the G/P regimen for patients with chronic kidney disease, who currently have limited HCV treatment options." "At no other time in history has the goal of eliminating hepatitis C in Canada been within reach like it is now, said Stphane Lassignardie, louis vuitton neverfull articles de voyage General Manager, AbbVie Canada. "We are firmly committed to seeing this goal accomplished. As such, we have invested significantly in recent years in clinical trials in Canada for our investigational, pan genotypic G/P regimen and will continue collaborating with Health Canada to help provide a cure for as many Canadians as possible living with HCV." AbbVie's NDS 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, including 174 patients in Canada, across all major HCV genotypes and special populations. Patient populations studied included GT1 6, those new and experienced to antiviral 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 registrational program for G/P 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. Food and Drug Administration (FDA) for the treatment of GT1 6 chronic HCV. And on September 30, 2016, AbbVie announced that G/P was granted Breakthrough Therapy Designation by the FDA for genotype 1 patients not cured with prior direct acting antivirals. G/P is an investigational product and its safety and efficacy have not been established. About AbbVie's HCV Clinical Development Program AbbVie's Glecaprevir/Pibrentasvir (G/P) 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. G/P is an investigational, pan genotypic regimen 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 CKD, including patients on dialysis. G/P is a louis vuitton alma vernis gm once daily regimen that combines two distinct antiviral agents. G/P is a fixed dose combination of glecaprevir (300mg), an NS3/4A protease inhibitor, and pibrentasvir (120mg), an NS5A inhibitor, dosed once daily as three oral tablets. Glecaprevir (GLE) was discovered during the ongoing collaboration between AbbVie and Enanta Pharmaceuticals for HCV protease inhibitors and regimens that include protease inhibitors. Patients who achieve a sustained virologic response at 12 weeks post treatment (SVR12) are considered cured of hepatitis C. Patients who are treatment naive or not cured with previous IFN based treatments ([peg]IFN +/ RBV or SOF/RBV +/ pegIFN).
About AbbVie Canada 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 kanye west x louis vuitton shoes price 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 more than 28,000 people worldwide and markets medicines in more than 170 countries.
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