EC approves label update for BMS’ Daklinza

The European Commission has approved an updated label for Bristol-Myers Squibb’s Daklinza 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.

“The burden of hepatitis C – and genotype 3, specifically – remains significant in many parts of Europe,” said Graham R. Foster, FRCP, Ph.D., Professor of Hepatology, Blizard Institute, Queen Mary University of London. “Despite advances in therapy, genotype 3 HCV patients are still some of the most challenging to treat with direct-acting antivirals. The cure rates achieved by Daklinza in combination with sofosbuvir for 12 weeks represent a positive step forward for genotype 3 patients without cirrhosis.”

Updated Daklinza label based on data from the ALLY-3 clinical trial

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 removes the requirement for ribavirin and reduces treatment duration to 12 weeks for patients without cirrhosis.

The European Commission’s approval is based on data from the Phase 3 open-label ALLY-3 clinical trial. In the trial, 152 patients with chronic HCV genotype 3 infection and compensated liver disease received Daklinza  plus sofosbuvir once daily for 12 weeks and were monitored for 24 weeks post-treatment. The co-primary endpoints were defined as HCV RNA below the lower limit of quantification (LLOQ) at post-treatment week 12 (SVR12) in each treatment group. The Daklinza plus sofosbuvir regimen demonstrated overall SVR12 in 90% of treatment-naïve and 86% of treatment-experienced chronic HCV genotype 3 patients. SVR12 rates were higher (96%) in genotype 3 patients without cirrhosis, regardless of treatment history. In the more difficult-to-treat patients with cirrhosis, SVR12 rates were reduced (63%) following the 12 weeks of treatment with the Daklinza plus sofosbuvir regimen.