Marketing validated for Bristol-Myers Squibb HCV treatment in EU
Daclatasvir is an investigational NS5A complex inhibitor used to treat adults with chronic hepatitis C with compensated liver disease, including genotypes one, two, three and four. The application to the EMA seeks the approval of DCV for use in combination with other agents to treat chronic HCV. Bristol-Myers Squibb said the MAA validation represents the start of an accelerated regulatory review for DCV.
"Our extensive clinical trial program has demonstrated that daclatasvir has potential use as a foundational agent for multiple HCV treatment regimens," Brian Daniels, the senior vice president of global development and medical affairs research and development at Bristol-Myers Squibb, said. "If daclatasvir is approved, we would focus on helping to ensure its availability to patients with limited treatment options and would work with EU health authorities to ensure access is achieved as quickly as possible."
In previous trials, DCV was studied in more than 5,500 patients in various all-oral regimens and with the current interferon-based standard of care. DCV demonstrated a low drug-drug interaction profile, which supports its potential use in multiple treatment regimens and in individuals with co-morbidities.
According to Bristol-Myers Squibb, an estimated nine million people are living in the European Union with hepatitis C. The company said the burden of liver disease and other morbidities from HCV infection is significant in the EU.