Regulatory

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 needs.

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 liver damage.

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.