Bristol-Myers Squibb's Daklinza gains positive CHMP opinion for hepatitis C

The European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion backing Bristol-Myers Squibb's experimental drug Daklinza (daclatasvir) for use in combination with other therapies to treat chronic hepatitis C virus (HCV) infection in adults, the company said Friday. The drugmaker indicated that "this is the first positive opinion given by the CHMP for an NS5A complex inhibitor."

The EMA said the recommendation was supported by data from a clinical trial evaluating Daklinza in combination with Gilead Sciences' Sovaldi (sofosbuvir), with or without ribavirin, in patients infected with genotype 1, 2 or 3 HCV. The regulator noted that a sustained virologic response was observed in all patients who had failed previous therapy consisting of an NS3/4A inhibitor plus pegylated interferon and ribavirin. Further, it said these findings were supported by a study testing Daklinza plus pegylated interferon and ribavirin in patients with genotype 4 infection, and by several Phase IIb trials of the drug in other combinations. According to the agency, Daklinza demonstrated "convincing efficacy, in particular in combination with [Sovaldi], with an overall good safety profile."

Elliott Levy, Bristol-Myers Squibb's head of specialty development, noted that more than 2000 HCV patients with advanced liver disease have already been treated with a regimen of Daklinza plus Sovaldi through the company's early access programmes in Europe. The drugmaker also noted that ongoing and completed Daklinza studies have included more than 5500 patients in a variety of all-oral regimens and with current interferon-based standard of care.

Daklinza was granted an accelerated assessment by the EMA earlier this year. In February, the FDA granted breakthrough therapy status for Bristol-Myers Squibb's all-oral combination of Daklinza plus the NS3 protease inhibitor asunaprevir, with a target review date of November 30. Meanwhile, the same regimen is under review by Japanese regulators and the company said a decision "is expected soon."

For related analysis of the hepatitis C market, see Hepatitis C: KOL Insight and Consensus Outlook.

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