FDA OKs BMS’ Hepatitis C Drug
The US Food and Drug Administration (FDA) has approved Bristol-Myers Squibb’s Daklinza (daclatasvir) for use with sofosbuvir to treat hepatitis C virus (HCV) genotype 3 infections. Daklinza is the first drug that has demonstrated safety and efficacy to treat genotype 3 HCV infections without the need for co-administration of interferon or ribavirin, two FDA-approved drugs also used to treat HCV infection, according to the FDA. Genotype 3 is estimated to affect 12% of chronic HCV patients in the US and is the second most common hepatitis C genotype globally after genotype 1.
Daklinza is an inhibitor of NS5A with dual modes of anti-viral activity that inhibits both RNA replication and virion assembly. In in vitro studies, Daklinza has shown anti-viral activity across genotypes 1-6, with EC50 values from picomolar to low nanomolar against wild type replicons. Daklinza will be available and begin shipping within a week
n July 2014, Japan became the first countr approve the use of a daclatasvir-based regimen for the treatment of chronic HCV. Since then, daclatasvir-based regimens have been approved across Europe, as well as numerous other countries in Central and South America, the Middle East, and the Asia-Pacific region.
Source: Bristol-Myers Squibb and FDA