EU approves Daklinza (daclatasvir) + Sovaldi(sofosbuvir) for use in genotype 3 Hepatitis C patients without cirrhosis over 12 weeks- BMS.

BMS announced that the European Commission has approved an updated label for Daklinza (daclatasvir) for the treatment of genotype 3 chronic hepatitis C (HCV). The update allows the use of Daklinza in combination with sofosbuvir for 12 weeks in patients without cirrhosis in all 28 Member States of the European Union, and marks the first time these patients with genotype 3 HCV have a once-daily, all-oral treatment regimen of this shorter duration.

Comment: In August 2014, Daklinza was approved by the European Commission for use in combination with other medicinal products across genotypes 1, 2, 3 and 4 for the treatment of chronic HCV infection in adults. The original label included treatment of patients with genotype 3 (with or without compensated cirrhosis and/or treatment-experienced) with Daklinza and sofosbuvir and ribavirin, for 24 weeks. The updated label, which removes the requirement for ribavirin and reduces treatment duration to 12 weeks for patients without cirrhosis, is based on data submitted to the European Medicines Agency and the Committee for Medicinal Products for Human Use from the ALLY-3 clinical trial.