Disease specific news: EU gives backing to hepatitis B Viread
28 Apr 2008

The European Commission has given its approval to the marketing of Viread (tenofovir disoproxil fumarate) as a treatment for chronic hepatitis B.

Viread has received approval for use across the EU's 27 member states for compensated liver disease, with evidence of active viral replication, persistently elevated serum alanine aminotransferase (ALT) levels and histological evidence of active inflammation and/or fibrosis.

Drug maker Gilead said that the decision for approval was based primarily on results from two ongoing Phase III trials investigating the safety, tolerability and efficacy of the drug compared to Hepsera (adefovir dipivoxil).

"Viread has many of the preferred qualities of an antiviral treatment: rapid and profound viral suppression, a well-established safety profile with more than one million years of patient experience, and convenient once-daily administration," Kevin Young, executive vice president at Gilead Sciences said.

"Now that Viread is approved for chronic hepatitis B in Europe, our top priority is working to ensure that all individuals who need the medication have access to it as quickly as possible," he added.

Applications for the drug are currently pending in the US, Canada and Australia.

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