EMA panel recommends approval of Daklinza for patients with HCV

The Committee for Medicinal Products for Human Use of the European Medicines Agency has recommended that Daklinza be approved to treat chronic hepatitis C virus in adults, according to a report from the committee.

Daklinza (daclatasvir, Bristol-Myers Squibb), an NS5A complex inhibitor, was looked upon favorably based on data from multiple studies with other HCV agents, including sofosbuvir (Sovaldi, Gilead Sciences). CHMP’s recommendation will be addressed by the European Commission, which has the authority to approve the drug for the European Union.

“Through Bristol-Myers Squibb’s Early Access Programs in Europe, more than 2,000 HCV patients with advanced liver disease have already been treated with Daklinza, in combination with sofosbuvir,” Elliot Levy, head of specialty development at Bristol-Myers Squibb, said in a company press release. “We anticipate that, if approved, Daklinza-based regimens will play a significant role in treating HCV patients with high unmet medical needs across Europe.”

Daklinza is beneficial when used in combination with other drugs because of its ability to inhibit viral replication in infected host cells. This can lead to the eradication of the virus, correlating to a cure for HCV, according to the EMA report.

The committee recommends that only clinicians experienced in treating patients with chronic HCV prescribe the 30-mg or 60-mg oral tablet.

More than 5,500 patients have been included in studies with daclatasvir regimens, and the treatment has been generally well tolerated, according to the BMS release.

Marketing applications for Daklinza-based regimens are still pending in the US and Japan; the FDA granted the drug priority review status and set a review date of Nov. 30.