EMA advises on compassionate use of sofosbuvir for hepatitis C

25 October 2013

The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has given an opinion on the use of sofosbuvir, for chronic (long-term) hepatitis C virus (HCV) infection, in a compassionate-use program.

It is the third time a compassionate-use program has been assessed at the European Union (EU) level. At national level, they are intended to give patients with a life-threatening, long-lasting or seriously disabling disease who have no available treatment options access to treatments that are still under development and that have not yet been authorized. An application for authorization of sofosbuvir was submitted by US biotech major Gilead Sciences (Nasdaq: GILD) in April 2013. While it is currently under evaluation by the CHMP, Sweden has requested a CHMP opinion on the conditions under which early access to sofosbuvir in combination with other agents could be given specifically for patients before or after liver transplantation.

Conditions of use

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