AbbVie’s 8-week hepatitis C drug granted early access in UK

A special Early Access to Medicines (EAMs) status has been granted in the UK to AbbVie’s as-yet-unapproved treatment for hepatitis C. The glecaprevir/pibrentasivr (g/p) combination is a ‘pan-genotypic’ drug  currently under review by the European Medicines Agency, and is part of a rapid evolution in treatments for the potentially deadly liver infection. AbbVie  is looking to compete with Gilead’s Epclusa, which was the first pan-genotypic hep C drug to

AbbVie Submits New Drug Application to U.S. FDA for its Investigational Regimen of Glecaprevir/Pibrentasvir (G/P) for the Treatment of All Major Genotypes of Chronic Hepatitis C

If approved, G/P will provide an eight week once-daily, ribavirin-free treatment option for HCV patients without cirrhosis across all major genotypes AbbVie's investigational regimen was granted Breakthrough Therapy Designation by the FDA for genotype 1 patients not cured with prior direct-acting antivirals AbbVie is on track to submit a Marketing Authorization Application for G/P in the European Union in early 2017 NORTH CHICAGO, ...

Eight Weeks of Treatment with AbbVie’s Investigational, Pan-Genotypic Regimen of Glecaprevir/Pibrentasvir (G/P) Achieved High SVR Rates Across All Major Genotypes of Chronic Hepatitis C

 97.5 percent of chronic HCV infected patients without cirrhosis and new to treatment across all major genotypes (GT1-6) achieved SVR12 with 8 weeks of G/P Across the 8-week arms of three registrational studies, no patients discontinued treatment due to adverse events G/P is an investigational, pan-genotypic, once-daily, ribavirin-free regimen for the treatment of chronic HCV NORTH CHICAGO, Ill., Nov. 11, 2016 /PRNewswire/ -- AbbVie (N...