Daclatasvir OK’d for accelerated review as HCV treatment by European Medicines Agency

The European Medicines Agency has validated the marketing authorization application by Bristol-Myers Squibb for daclatasvir, marking the beginning of an accelerated review process for the potential treatment for patients with chronic hepatitis C, according to a news release.

Daclatasvir, an investigational NS5A complex inhibitor, is intended for use by patients with compensated liver disease and HCV genotypes 1, 2, 3 and 4, the release said. The application calls for its use in conjunction with other agents, including sofosbuvir.

The application is supported by a series of studies that evaluated more than 5,500 patients using various all-oral regimens along with the current interferon-based standard of care, according to the release said. Daclatasvir has demonstrated a low drug-drug interaction profile and pan-genotypic potency. It also has been generally well tolerated by patients.

“Our extensive clinical trial program has demonstrated that daclatasvir has potential use as a foundational agent for multiple HCV treatment regimens,” Brian Daniels, MD, senior vice president of global development and medical affairs, research and development, for Bristol-Myers Squibb, said in the release. “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.”

Bristol-Myers Squibb already has filed for approval in Japan of a daclatasvir-based therapy for HCV genotype 1b patients, the release said.