European regulators are active to give a quick review of AbbVie’s investigational, pan-genotypic procedure of glecaprevir (ABT-493)/pibrentasvir (ABT-530) (G/P) for the cure of chronic hepatitis C (HCV) in all major genotypes.
According to the firm, the G/P procedure could deliver a shorter, eight week, once-daily, ribavirin-free cure option for the preponderance of HCV patients without cirrhosis and a supplementary treatment alternative to patients with compensated cirrhosis (Child-Pugh A).
The treatment is also projected to look forward the needs of patients with detailed treatment trials, such as those with severe chronic kidney disease (CKD) and those not treated with previous direct-acting antiviral (DAA) treatment.
The application comprises data from eight registrational studies in AbbVie’s G/P clinical growth programme, concerning more than 2,300 patients across all main HCV genotypes and special populations, which was intended to consider a faster path to virologic cure for all foremost genotypes and with the aim of covering areas of sustained unmet need.
According to AbbVie’s chief scientific officer Michael Severino,”We are contented at the prospective of our investigational, pan-genotypic regimen and that it has been approved enhanced valuation by the EMA. We will work closely with the EMA as we continue our assurance to possibly offer a treatment for as many people living with HCV as possible”.
Date: 24th January 2017
http://www.pharmatimes.com/news/speedy_eu_review_for_abbvies_pan-genotypic_hep_c_therapy_1184944