The scientific committee of the European Medicines Agency recommended the approval of daclatasvir a new direct-acting antiviral for treatment of hepatitis C virus (HCV) on 26 June. Daclatasvir is an NS5A inhibitor, which means that it stops HCV replication by blocking the action of the NS5A protein.
It has been recommended for use in the European Union in combination with other direct-acting antivirals. Full details of the licensing indication will be released when daclatasvir receives marketing approval, which is expected by mid-August or early September. Daclatasvir has been developed by Bristol-Myers Squibb and will be marketed under the brand name Daklinza in the European Union.
A two-drug combination of daclatasvir and asunaprevir was approved in July for the treatment of genotype 1 infection in Japan where approximately 70% of people with hepatitis C have genotype 1b infection. This two-drug combination is potent for genotype 1b, but less efficient for the 1a subtype.
Daclatasvir is the first NS5A inhibitor to be approved. Several other pharmaceutical companies are developing NS5A inhibitors as part of combinations of direct-acting antivirals. The European Association for the Study of the Liver (EASL) has recommended that daclatasvir may be used in combination with either sofosbuvir or with pegylated interferon and ribavirin for the treatment of HCV genotypes 1, 3 or 4. Other combination products are likely to receive European marketing approval in 2015.
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