10.12.07
Gilead Sciences, Inc. has submitted a sNDA to the FDA and a Type II variation to the EMEA for marketing approval of Viread for the treatment of chronic hepatitis B in adults. Viread is currently approved in the U.S. and EU for the treatment of HIV as part of a combination antiretroviral therapy.
The submissions include data from two Phase III trials, Studies 102 and 103, in patients chronically infected with the hepatitis B virus (HBV). These studies evaluate the safety, efficacy and tolerability of Viread compared to Gilead's Hepsera.
"The active ingredient in Viread—tenofovir disoproxil fumarate—is the most widely prescribed molecule for the treatment of HIV in the U.S.," said Franck Rousseau, M.D., vice president, clinical research, Gilead Sciences. "With positive data from two pivotal studies now available, we look forward to extending the use of this important therapy to patients with chronic hepatitis B."
Chronic hepatitis B affects more than 400 million people worldwide. Complications include liver cancer and cirrhosis and kills as many as 1.2 million people each year. Anti-HBV drugs can have beneficial effects on chronic hepatitis B throughout the course of infection, potentially preventing liver damage and liver cancer.
The submissions include data from two Phase III trials, Studies 102 and 103, in patients chronically infected with the hepatitis B virus (HBV). These studies evaluate the safety, efficacy and tolerability of Viread compared to Gilead's Hepsera.
"The active ingredient in Viread—tenofovir disoproxil fumarate—is the most widely prescribed molecule for the treatment of HIV in the U.S.," said Franck Rousseau, M.D., vice president, clinical research, Gilead Sciences. "With positive data from two pivotal studies now available, we look forward to extending the use of this important therapy to patients with chronic hepatitis B."
Chronic hepatitis B affects more than 400 million people worldwide. Complications include liver cancer and cirrhosis and kills as many as 1.2 million people each year. Anti-HBV drugs can have beneficial effects on chronic hepatitis B throughout the course of infection, potentially preventing liver damage and liver cancer.