EU Panel Endorses Daclatasvir (Daklinza) for Chronic Hep C

Megan Brooks

Disclosures

June 27, 2014

The European Medicines Agency (EMA) Committee for Medicinal Products for Human Use (CHMP) has endorsed daclatasvir (Daklinza, Bristol-Myers Squibb) to treat adults with chronic hepatitis C virus (HCV) infection, in combination with other drugs.

Daclatasvir is the first in a new class of antivirals that block the action of NS5A, a protein essential for HCV replication.

The positive opinion on daclatasvir is supported by a pivotal trial that evaluated the drug in patients infected with HCV genotype 1, 2, and 3, in combination with sofosbuvir with or without ribavirin, the EMA notes in a statement.

As reported by Medscape Medical News, the trial showed high cure rates with the daclatasvir/sofosbuvir combination in a range of patients, including patients who had previously received treatment with an NS3/4A inhibitor in combination with pegylated interferon and ribavirin. "All such patients in the study reached a sustained virologic response, which is the goal of antiviral therapy for HCV," the EMA notes.

Daclatasvir also proved effective in combination with pegylated interferon and ribavirin in a trial of patients with genotype 4 infection.

The most common adverse effects with daclatasvir when used in combination with other drugs were fatigue, headache, and nausea.

HCV infection is a "major European public-health challenge," the EMA says, occurring in 0.4% to 3.5% of the population in different European Union member states. HCV is most common single cause of liver transplantation in the European Union.

Daclatasvir was evaluated by accelerated assessment, a regulatory pathway to help speed up access to new medicines where there is an unmet medical need, the EMA says.

The CHMP opinion on daclatasvir will now be forwarded to the European Commission, which will make a final decision.

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