Bristol-Myers Squibb receives new hepatitis C approvals for Daklinza

Bristol-Myers Squibb has announced that its hepatitis C drug Daklinza has been approved by the European Commission in a number of new indications.

The expanded label allows Daklinza to be used in combination with sofosbuvir in hepatitis C virus patients with decompensated cirrhosis, HIV-1 coinfection and post-liver transplant recurrence of hepatitis C.

Daklinza remains contraindicated in combination with medicinal products that strongly induce CYP3A and P-glycoprotein transporter, as this may lead to lower exposure and loss of efficacy. It is also not suitable for use as a monotherapy.

The drug is approved for use in combination with other medicinal products across genotypes 1, 2, 3 and 4 for the treatment of chronic hepatitis C infections in adults. The Daklinza plus sofosbuvir regimen is the only approved 12-week all-oral treatment for genotype 3 hepatitis C patients without cirrhosis.

Dr Douglas Manion, head of specialty development at Bristol-Myers Squibb, said: "The European Commission's approval of these new indications for Daklinza is an important step forward for a significant group of patients with chronic hepatitis C."

The UK's National Institute for Health and Care Excellence endorsed the drug for NHS use for the treatment of genotypes 1, 3 and 4 chronic hepatitis C infections last year.