Six new drugs recommended for approval by EMA’s CHMP

27 June 2014

At its end-June meetings, the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has recommended six new medicines for approval.

The CHMP has recommended granting a marketing authorization for Bristol-Myers Squibb’s (NYSE: BMY) Daklinza (daclatasvir) in combination with other medicinal products for the treatment of chronic hepatitis C virus (HCV) infection in adults.

The positive opinion granted by the CHMP for the marketing authorization of Daklinza is supported by a pivotal trial in which the medicine was evaluated in HCV genotype-1, -2 and -3 infected patients, in combination with sofosbuvir with or without ribavirin. The medicine showed convincing efficacy, in particular in combination with sofosbuvir, with an overall good safety profile, the EMA stated.

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