Bristol-Myers’s hepatitis C infection combination therapy gets European approval

Daklinza is approved for use in combination with other medicinal products across genotypes 1, 2, 3 and 4 to treat HCV infection in adults.

The combination of Daklinza and sofosbuvir, which is an all-oral, interferon-free regimen, provided cure rates of up to 100% in clinical trials, including patients with advanced liver disease, genotype 3 and those who have previously failed treatment with protease inhibitors.

In the European Union (EU), Daklinza is approved for use in combination with other medicinal products, which provides a shorter treatment duration of about 12 or 24 weeks compared to 48 weeks of treatment with interferon- and ribavirin-based regimens.

Bristol-Myers Squibb head of Worldwide Commercialization Emmanuel Blin said the eradication of HCV is in sight, and with the 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.

"We are proud to have discovered, developed and now brought to market this first-in-class NS5A replication complex inhibitor," Blin said.

"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 European approval allows the company to market Daklinza in all 28 member states of the EU and it is supported by data from multiple studies, including an open-label, randomized study of the combination therapy in genotypes 1, 2, and 3.

Image: A Bristol-Myers Squibb R&D facility Princeton Rd, Princeton, New Jersey, US. Photo: courtesy of Coolcaesar