Gilead Sciences Receives CHMP Recommendation for Harvoni

Gilead Sciences reports that the Committee for Medicinal Products for Human Use (CHMP), the scientific committee of the European Medicines Agency has adopted a positive opinion on the company's marketing authorization application (MAA) for Harvoni, an investigational once-daily tablet combining the NS5A inhibitor ledipasvir (LDV) 90 mg and the nucleotide analog polymerase inhibitor sofosbuvir (SOF) 400 mg, for the treatment of chronic hepatitis C virus infection in adults.

The CHMP opinion was adopted following an accelerated review procedure. The CHMP's recommendation will now be reviewed by the European Commission, which has the authority to approve medicines for use in the 28 countries of the European Union.

Sofosbuvir as a single agent was granted marketing authorization in the European Union on January 16, 2014 under the trade name Sovaldi. Sovaldi is also approved for use in the United States, Canada, Australia, New Zealand, Egypt, Switzerland, and Turkey.

Source: Gilead Sciences

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