Bristol-Myers hepatitis C drug Daklinza cleared for marketing in USA

US pharma major Bristol-Myers Squibb’s (NYSE: BMY) Daklinza (daclatasvir), an NS5A replication complex inhibitor, has been approved by the US Food and Drug Administration.

This approval marks the first time patients with chronic hepatitis C virus (HCV) genotype 3 have a 12-week, once-daily, all-oral treatment option. Daklinza, which was approved in Europe nearly a year ago (The Pharma Letter August 27, 2014), will be available and begin shipping within a week.

Daklinza is indicated for use with sofosbuvir for the treatment of patients with chronic HCV genotype 3 infection. Sustained virologic response (SVR) rates are reduced in HCV genotype 3-infected patients with cirrhosis receiving this regimen. The recommended dosage of Daklinza is 60 mg in combination with sofosbuvir (the active ingredient of Gileads’ blockbuster hepatitis C drug Sovaldi) for 12 weeks.