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Article: Gilead's Hepsera for hep B OKed in Europe.
- Article from:
- Pharma Marketletter
- Article date:
- March 17, 2003
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Gilead Sciences has been granted marketing approval in the European Union for Hepsera (adefovir dipivoxil 10mg) in the treatment of chronic hepatitis B in adults with compensated liver disease and evidence of active viral replication, persistently-elevated serum alanine aminotransferase levels and histological evidence of active liver inflammation and fibrosis.
Analysts at Merrill Lynch note that the European approval of Hepsera has come some months earlier than expected, as they had tipped EU registration for the second quarter of this year. Nevertheless, they are not altering their estimates for Hepsera sales or expenses related to the drug in 2003, as Gilead ...