|Merck's hepatitis C drug receives positive recommendation from EMA|
|By Deborah Sterescu - Proactiveinvestors.com|
|Friday, 20 May 2011 20:36|
The positive opinion from the European Medicines Agency (EMA) will now be reviewed by the European Commission, which gives marketing authorization valid in all 27 EU member countries, as well as EEA members.
Hepatitis C is an infectious disease affecting the liver, and is often asymptomatic, but once established, chronic infection can progress to scarring of the liver, and eventually liver failure or other complications including liver cancer.
The drug, which this month was approved by the US FDA, is intended to treat chronic hepatitis C virus, in combination with peginterferon alfa and ribavirin, in adult patients with liver disease who have been previously untreated or who have failed prior therapy.
Boceprevir is an anti-viral drug designed to interfere with the ability of the hepatitis C virus to replicate, by inhibiting a key viral enzyme.
New Jersey-based Merck said the positive opinion from the EMA was based on efficacy and safety results from two large phase three clinical studies that tested 1,500 patients at sites in the EU and US.