The approval follows an accelerated assessment by the Committee for Medicinal Products for Human Use (CHMP).
Bristol-Myers Squibb Company (NYSE:BMY) today announced that the European Commission has approved (daclatasvir), a potent, pan-genotypic NS5A replication complex inhibitor (), for use in combination with other medicinal products across genotypes 1, 2, 3 and 4 for the treatment of chronic hepatitis C virus (HCV) infection in adults. when used in combination with sofosbuvir, is an all-oral, interferon-free regimen that provided cure rates of up to 100% in clinical trials, including patients with advanced liver disease, genotype 3 and those who have previously failed treatment with protease inhibitors. is the first NS5A complex inhibitor approved in the European Union (EU) and will be available for use in combination with other medicinal products, providing a shorter treatment duration (12 or 24 weeks) compared to 48 weeks of treatment with interferon- and ribavirin-based regimens.
Press release: http://bit.ly/1ooINJl