Bristol-Myers’ hep C drug Daklinza approved in Europe

US pharma major Bristol-Myers Squibb (NYSE: BMY) says that the European Commission has approved Daklinza (daclatasvir), a pan-genotypic NS5A replication complex inhibitor (in vitro), for use in combination with other medicinal products across genotypes 1 - 4 for the treatment of chronic hepatitis C virus (HCV) infection in adults.

Daklinza is the first NS5A complex inhibitor approved in the European Union and will be available for use in combination with other medicinal products, providing a shorter treatment duration (12 or 24 weeks) compared to 48 weeks of treatment with some interferon- and ribavirin-based regimens.

Emmanuel Blin, head of worldwide commercialization at B-MS, commented: "We look forward to our continued work with EU health authorities to ensure Daklinza-based regimens are available to patients as quickly as possible."
Daklinza was recently approved in Japan in combination with Sunvepra (asunaprevir), a NS3/4A protease inhibitor (The Pharma Letter July 7). The Daklinza+Sunvepra dual regimen is Japan’s first all-oral, interferon- and ribavirin-free treatment regimen for patients with genotype 1 chronic HCV infection, including those with compensated cirrhosis. Applications for the daclatasvir Dual Regimen are also under review by the US Food and Drug Administration, which granted priority review status and set a target review date under the Prescription Drug User Fee Act (PDUFA) of November 30, 2014.

Efficacy in combination with Sovaldi

When used in combination with sofosbuvir (Gilead Sciences’ already mega-blockbuster Sovaldi brand), this new drug represents an all-oral, interferon-free regimen that provided cure rates of up to 98% in patients with HCV genotype 1, 89% in patients with genotype 3 and 100% in genotype 4, as demonstrated in clinical trials, says B-MS. Studies have shown daclatasvir to be effective in patients with advanced liver disease, those with HCV genotype 3 and those who have previously failed treatment with protease inhibitors.