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CHMP recommends EMA approval for Daklinza

Europe's Committee for Medicinal Products for Human Use (CHMP) recommends that the European Medicines Agency (EMA) approve Bristol-Myers Squibb's (BMY) Daklinza (daclatasvir) in combination with other medicinal products as a treatment for adults with chronic hepatitis C infection. Daclatasvir is an investigational pan-genotypic NS5A inhibitor. CHMP's recommendation is its first positive opinion for this class of drug.

Ongoing and completed Daklinza studies have included more than 5,500 patients in a variety of all-oral regimens and with the current interferon-based standard of care. Patients receiving Daklinza-based regimens have tolerated them well with low rates of discontinuation.

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