Bristol-Myers Squibb's hepatitis C therapy Daklinza gains EU approval for combination use

Bristol-Myers Squibb said Wednesday that the European Commission approved Daklinza (daclatasvir) for use in combination with other drugs across genotypes 1, 2, 3 and 4 for the treatment of chronic hepatitis C virus (HCV) infection in adults. The company noted that the oral medicine is the first NS5A complex inhibitor approved in Europe and will be available for use in combination with other therapies, providing treatment durations of 12 weeks or 24 weeks, versus 48 weeks for interferon- and ribavirin-based regimens.

The decision, which follows a positive opinion from the European Medicines Agency's Committee for Medicinal Products for Human Use in June, was supported by data from a number of studies, including a trial investigating Daklinza with Gilead Sciences' Sovaldi (sofosbuvir) in genotypes 1, 2, and 3. Bristol-Myers Squibb noted that results showed that the combination of Daklinza and Sovaldi achieved sustained virologic response 12 weeks after the end of treatment in 99 percent of treatment-naïve patients with HCV genotype 1, 100 percent of patients with genotype 1 who had failed treatment with either Vertex Pharmaceuticals' Incivek (telaprevir) or Merck & Co.'s Victrelis (boceprevir), 96 percent of those with genotype 2 and 89 percent of those with genotype 3.

Emmanuel Blin, head of worldwide commercialisation at Bristol-Myers Squibb, remarked "we look forward to our continued work with EU health authorities to ensure Daklinza-based regimens are available to patients as quickly as possible." Daklinza was approved in Japan In July in combination with the NS3/4A protease inhibitor Sunvepra (asunaprevir) as the country's first all-oral, interferon- and ribavirin-free treatment regimen for patients with genotype 1 chronic HCV infection, including those with compensated cirrhosis.

In February, the FDA granted breakthrough therapy status for Bristol-Myers Squibb's combination of Daklinza and asunaprevir, with a regulatory filing made in April assigned a target review date of November 30.

For more information on the hepatitis C market, see Hepatitis C: KOL Insight and Consensus Outlook.

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