EU Approves Daklinza for the Treatment of Hepatitis C

The European Commission has granted Bristol-Myers Squibb approval for an all-oral drug regimen for the treatment of four genotypes of chronic hepatitis C infection, according to a statement from the company.

The drug daclatasvir will be marketed as Daklinza and used in combination with other medicine across genotypes 1, 2, 3, and 4 to treat chronic hepatitis C virus (HCV),Bristol-Myers Squibb said in a news release. Daklinza is the first NS5A complex inhibitor approved in the European Union (EU) and a new class of drug that disrupts HCV, inhibiting both viral replication and assembly, according to the statement.

Hepatitis C is a blood borne virus dubbed a silent killer because over time it can cause severe liver damageif left untreated. Health officials estimate that up to 150 million people worldwide, including 9 million in the EU, have chronic infection of the virus, which can remain in the body for years without symptoms.

When Daklinza was tested in clinical trials as a combination with Gilead Sciences’ Sovaldi (sofosbuvir), the regimen had up to 100% cure rates (sustained virologic response), even among patients with advanced liver disease and those whose treatment with protease inhibitors failed, the statement said.

The EU approval covers various therapy combinations of Daklinza with Sovadi — with and without interferon and ribavirin – depending on HCV genotype and liver disease stage. Treatment durations range from 12 to 24 weeks and may include 48 weeks of interferon for some HCV genotype 4 patients, according to information released by the company.

“The eradication of HCV is in sight, and with today’s approval, Daklinza, in combination with other agents, will be an important option to achieve cure across many HCV genotypes and patient types for those in the EU who are in dire need of new treatment choices,” Emmanuel Blin, head of Bristol-Myers Squibb worldwide commercialization, said in the statement.

“We are proud to have discovered, developed and now brought to market this first-in-class NS5A replication complex inhibitor. We look forward to our continued work with EU health authorities to ensure Daklinza-based regimens are available to patients as quickly as possible.”

The approval of Daklinza covers 28 member states in the European Union, with commercial availability to be determined by individual member states. To gain approval of the drug application, which had been given accelerated review, Bristol-Myers Squibb submitted data from multiple studies to EU regulators.

Study results showed that a Daklinza and Solvaldi regimen produced high sustained virologic response rates among HCV patients with genotype 1 who had not previously been treated (99%), and others who had failed with treatments of telaprevir and boceprevir (100%), as well as patients with genotype 2 (96%) and the harder to treat patients with genotype 3 (89%), the company said.

The drug was shown to be safe among diverse patient populations and well tolerated, with low rates of serious adverse events and patients discontinuing the study due to adverse events, according to the statement.

Earlier this year, the Japanese Ministry of Health, Labor and Welfare approved Daklinza for use in combination with Sunvepra (an NS3 protease inhibitor) as an all-oral regimen for patients with genotype 1 chronic HCV infection and patients with compensated cirrhosis. Bristol-Myers Squibb has filed a similar New Drug Application in the US with the FDA and has a target review date this year in late November.