EMA Advisory Committee Recommends Gilead’s Hepatitis C Combo Drug

The Committee for Medicinal Products for Human Use (CHMP), the scientific committee of the European Medicines Agency (EMA), has adopted a positive opinion for Gilead Sciences’ marketing authorization application (MAA) for Epclusa, an investigational, pan-genotypic, once-daily tablet containing the nucleotide analogue polymerase inhibitor sofosbuvir 400 mg and velpatasvir 100 mg, an investigational pan-genotypic NS5A inhibitor, for the treatment of chronic hepatitis C virus (HCV) infection.

The CHMP positive opinion was adopted following an accelerated review procedure, reserved for medicinal products expected to be of major public health interest. The 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, Norway, and Iceland.

Sofosbuvir as a single agent was granted marketing authorization in the European Union in January 2014, under the trade name Sovaldi. The fixed-dose combination of sofosbuvir and ledipasvir received marketing authorization in the European Union in November 2014, under the trade name Harvoni.

For 2015, Harvoni had sales of $13.8 billion and Sovaldi had sales of $5.3 billion.

Gilead has also submitted a regulatory application for sofosbuvir and velpatasvir n the United States. Gilead filed the new drug application in October 2015, and the US Food and Drug Administration (FDA) has set a target action date under the Prescription Drug User Fee Act (PDUFA) of June 28, 2016.

Source: Gilead Sciences

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