Gilead Sciences Inc announced that the European Commission granted Marketing Authorisation for Hepsera (adefovir dipivoxil 10 mg) in all 15 member states of the European Union. Hepsera 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. On November 21, 2002, the Committee for Proprietary Medicinal Products (CPMP), the scientific committee of the European Medicines Evaluation Agency (EMEA), issued a positive opinion on Hepsera.
More than 400 million people worldwide have chronic hepatitis B, which is caused by infection with the hepatitis B virus (HBV), and between one quarter and one third of these individuals are expected to develop progressive liver disease, such as cirrhosis and liver cancer. Approximately nine million people are chronically infected with HBV in Europe. An estimated one million people die annually from complications of chronic hepatitis B making it one of the leading causes of death worldwide.
"To date, the limitations of available hepatitis B drugs, such as poor tolerability and rapid development of viral resistance, have made them unsuitable or ineffective for many patients," said Professor Stephanos Hadziyannis, Department of Medicine, Henry Dunant Hospital, Athens, Greece. "In clinical studies, Hepsera significantly reduced disease progression in a wide range of patients. Broad efficacy, good tolerability and a low risk of resistance make Hepsera an important advancement in the treatment of chronic hepatitis B."
Hepsera is administered as a once-daily 10 mg tablet and works by blocking HBV DNA polymerase, an enzyme involved in the replication of the virus in the body. The U.S. Food and Drug Administration (FDA) cleared Hepsera for marketing in the United States on September 20, 2002. Regulatory filings for the drug also have been completed in Australia, Switzerland, Turkey and Canada, and additional regulatory filings are planned in other countries in the coming months.
"The approval of Hepsera by the European Commission comes less than a year after Gilead filed its Marketing Authorisation Application with the European authorities, demonstrating the important unmet medical need Hepsera will address for physicians and their patients with chronic hepatitis B," said John C. Martin, PhD, President and CEO, Gilead Sciences.