Gilead's New Hep C Combination Backed by EMA

Harvoni, the sofosbuvir/ledipasvir combination, received accelerated assessment and will now be sent to the European Commission for EU-wide marketing authorization.

The European Medicines Agency has recommended the authorisation of Harvoni (ledipasvir / sofosbuvir) for the treatment of chronic hepatitis C virus (HCV) infection in adults.

HCV infection is a major European public-health challenge. It affects between 0.4% and 3.5% of the population in different European Union (EU) Member States and is the most common single cause of liver transplantation in the EU.

Harvoni belongs to a new generation of antiviral products for chronic HCV infection that have high cure rates and have recently reshaped the treatment landscape for this disease. It is a combination of the active substances sofosbuvir and ledipasvir, which block the action of proteins which are essential for HCV to replicate - the protein NS5B for sofosbuvir and NS5A for ledipasvir.

These new regimens allow cure of patients with chronic HCV infection without the need for treatments involving interferons, medicines which are associated with poor tolerability and potentially serious side effects that rule out such treatment in a considerable proportion of HCV patients.

Press release from the European Medicines Agency: