Gilead
Sciences Seeks U.S. and European Marketing Approval for Tenofovir (Viread) for
Treatment of Chronic Hepatitis B Gilead
Sciences announced on October 11, 2007 that the company has submitted a supplemental
New Drug Application (sNDA) to the U.S. Food and Drug Administration (FDA) and
to the European Medicines Agency (EMEA) for marketing approval of Viread
(tenofovir) for the treatment of chronic hepatitis
B virus (HBV) infection in adult patients. Viread is already approved in the
U. S. and the European Union for the treatment
of HIV as part of combination antiretroviral therapy. Following
are excerpts from the Gilead announcement: The
[marketing] submissions [to US FDA and EMEA] contain data from two Phase III pivotal
clinical trials, Study
102 and Study
103, in patients chronically infected with the hepatitis B virus (HBV). These
studies evaluate the efficacy, safety, and tolerability of Viread compared to
Gilead's Hepsera (adefovir dipivoxil). Gilead announced
the primary results from Study 102 and 103 on June 6 and June 25, 2007, respectively.
"The active
ingredient in Viread -- tenofovir disoproxil fumarate -- is the most widely prescribed
molecule for the treatment of HIV in the United States," said Franck Rousseau,
MD, 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." "New
treatments are critically important in the fight against chronic hepatitis B,
a potentially life-threatening infection that impacts millions of people worldwide,"
said Eugene Schiff, MD, Chief of the Division of Hepatology and Director of the
Center for Liver Diseases at the University of Miami School of Medicine. "We've
made great progress in our ability to diagnose and treat the disease, but a significant
unmet medical need remains and ongoing efforts in research and development are
essential." |
More
about Hepatitis B Chronic
hepatitis B affects more than 400 million people worldwide. The complications
of chronic hepatitis B, which include liver cancer and cirrhosis, kill up to 1.2
million people each year, making it one of the world's top 10 causes of death.
In the United
States, an estimated 1.3 million people are currently living with chronic hepatitis
B, of whom more than half are Asian American. In the European region, one million
people are estimated to become infected with HBV each year and approximately 90,000
go on to develop chronic hepatitis B. While
there is no cure for the disease, anti-HBV medications can have beneficial effects
on chronic hepatitis B throughout the course of infection, potentially preventing
fatal liver damage and liver cancer. In many cases, this requires prolonged treatment
over the course of many months or years. Chart
of Experimental and Approved Therapies for Chronic Hepatitis B 
HIV and Hepatitis.com
Articles on Viread for the Treatment of Chronic Hepatitis B
Viread
Study 102 Viread
Study 103
10/16/07 Source
Gilead
Sciences. Gilead Submits Marketing Applications in the United States and European
for Viread (tenofovir disoproxil fumarate) for the Treatment of Chronic Hepatitis
B. Press Release. October 11, 2007. |
| FDA-approved
Monotherapies for HBV |
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