European approval of adefovir for hepatitis B
Simon Collins, HIV i-Base
The European Commission granted marketing authorisation for adefovir dipivoxil 10 mg (Hepsera) in all 15 member states of the European Union on 11 March 2003. Adefovir is indicated in Europe for the treatment of chronic hepatitis B in adults with compensated liver disease with evidence of active viral replication, persistently elevated serum alanine aminotranseferase (ALT) levels and histological evidence of active liver inflammation and fibrosis; or decompensated liver disease.
Adefovir is administered as a once-daily 10mg tablet and works by blocking HBV DNA polymerase, an enzyme involved in the replication of the virus in the body. The US Food and Drug Administration (FDA) cleared adefovir for marketing in the United States in September 2002.
The early access programme in France, Italy, Greece, Spain, Portugal, Germany, the United Kingdom, Canada and Australia, which Gilead says has provided adefovir to over 1,600 patients since June 2002, will continue until the drug is commercially available to patients in these countries. For more information regarding the Early Access Programme for adefovir in Europe, call +33 1 44 90 34 75.
Source: Gilead PR
Full prescribing information (pdf download):