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news.Gilead Sciences has announced that the European Commission has granted marketing authorization for Viread for the treatment of chronic hepatitis B in all 27 member states of the EU.
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A once-daily tablet, Viread works by blocking hepatitis B virus (HBV) DNA polymerase, the enzyme that is necessary for the virus to replicate in liver cells. This approval is based primarily on data from two ongoing Phase III clinical trials, Studies 102 and 103, in patients (n = 375) chronically infected with HBV who were new to HBV therapy (treatment-naive).
Viread has been approved in the EU for use in adult chronic HBV patients with 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.
Kevin Young, executive vice president, commercial operations at Gilead, 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.”