Bristol-Myers Squibb receives accelerated EU review for hepatitis drug

Bristol-Myers Squibb has announced that daclatasvir, its new treatment for chronic hepatitis C, has been granted accelerated regulatory review status by the European Medicines Agency.

The regulator has validated the company's marketing authorisation application for the investigational NS5A complex inhibitor, which is designed for use among adult hepatitis C patients with compensated liver disease, including genotypes 1, 2, 3 and 4.

Bristol-Myers Squibb seeks approval of daclatasvir for use in combination with other agents, including sofosbuvir, based on positive findings from an extensive clinical trial programme that has involved more than 5,500 patients.

It has been granted an accelerated review due to its potential to address a high unmet need in the EU.

Dr Brian Daniels, senior vice-president for global development and medical affairs at Bristol-Myers Squibb's research and development business, 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."

Last month, the company announced the sale of its diabetes business to AstraZeneca as part of wider efforts to reorient its strategic focus. It will also soon be discontinuing broad-based discovery work in the field of hepatitis C.