Bristol-Myers Squibb’s new hepatitis C drug receives CHMP backing

Bristol-Myers Squibb has announced that Europe's Committee for Medicinal Products for Human Use (CHMP) has recommended its new hepatitis C therapy Daklinza for regulatory approval.

The European Medicines Agency committee has endorsed the investigational, potent pan-genotypic NS5A complex inhibitor for use in combination with other medicinal products for the treatment of chronic hepatitis C virus (HCV) infections in adults.

It is the first drug in its category to be recommended for European approval, having demonstrated its potential benefits in clinical studies involving more than 5,500 patients.

Daklinza was recently included in the European Association for the Study of the Liver's clinical practice guidelines for the management of HCV infection across genotypes. Its EU marketing authorisation application was granted an accelerated review.

Elliott Levy, head of specialty development at Bristol-Myers Squibb, said: "We anticipate that, if approved, Daklinza-based regimens will play a significant role in treating HCV patients with high unmet medical needs across Europe."

The company also recently received a CHMP recommendation for a new indication of Eliquis, the anticoagulant therapy it developed alongside Pfizer.