Reuters Health Information (2005-03-30): US FDA clears Bristol-Myers new drug for chronic hepatitis B
US FDA clears Bristol-Myers new drug for chronic hepatitis B
Last Updated: 2005-03-30 16:00:34 -0400 (Reuters Health)
NEW YORK (Reuters) - Bristol-Myers Squibb Co. won U.S.
approval on Tuesday to sell its drug Baraclude (entecavir) for the
treatment of chronic hepatitis B, a Food and Drug Administration
spokeswoman and the company said.
Baraclude is an oral antiviral agent that can be taken once daily
and is designed to block replication of the virus by interfering with
its ability to infect cells.
Bristol-Myers Squibb submitted a new drug application to the FDA for
Baraclude on Sept. 29 and was granted a 6-month Priority Review, a
designation for experimental drugs that may address unmet medical
An FDA panel recommended approval for the drug earlier this month,
suggesting that clinical trial data showed Baraclude to be superior to
other hepatitis B treatments.
In a study that compared Baraclude with lamivudine, Baraclude showed
significant improvements in reducing viral levels and the amount of
However, preclinical testing of the drug "suggest a possible
carcinogenic risk in humans," Bristol researcher Lois Lehman-McKeeman
said earlier this month. The company plans to conduct a post-marketing
study over 5 to 8 years to monitor risks.
"With today's FDA approval of Baraclude, physicians have an
important new medication to treat hepatitis B," Dr. Robert Gish,
medical director of the California Pacific Medical Center's Liver
Transplant Program, said in a statement.