EC approves label update for Bristol-Myers Squibb’s Daklinza

The update enables the company to use Daklinza in combination with sofosbuvir for 12 weeks in patients without cirrhosis in all 28 Member States of the European Union.

Bristol-Myers said Daklinza is contraindicated in combination with medicinal products that strongly induce CYP3A and P-glycoprotein transporter, resulting in lower exposure and loss of efficacy.

The commission approved Daklinza in August last year for use in combination with other medicinal products across genotypes 1, 2, 3 and 4 to treat chronic HCV infection in adults.

The original label included treatment of patients with genotype 3 with Daklinza and sofosbuvir and ribavirin, for 24 weeks.

The updated label removes the need for ribavirin and reduces treatment duration to 12 weeks for patients without cirrhosis.

The updated treatment regimen for patients with cirrhosis is for Daklinza plus sofosbuvir with the optional use of ribavirin, which may be added based on clinical assessment of the patient. The treatment duration for these patients has not changed.

Genotype 3 is estimated to affecting 54.3 million people globally. It is the second most common HCV genotype worldwide.

It damages liver due to its relation with accelerated fibrosis progression. Recent research has indicated that the risk of cirrhosis for patients infected with HCV genotype 3 is 31% more than for those with HCV genotype 1.

Earlier this year, the US Food and Drug Administration gave its nod to Daklinza, marking the first approval of inhibitor in the country.

Image: Genotype 3 is estimated to affecting 54.3 million people globally. Photo: courtesy of Bristol-Myers Squibb Company.