New hepatitis drug wins approval by FDA

Mar 14 2005

An experimental hepatitis B drug has earned the praise of US health experts for its effectiveness and has been recommended by the US Food and Drug Administration (FDA) advisory panel to treat the liver disease in adults.

The drug called Baraclude won unanimous support from the scientific panel which said data supplied showed it to be superior to other hepatitis medications and was stronger than hepatitis drug telbivudine.

Lynn Paxton of the US Centres for Disease Control and Prevention (CDC), a member of the advisory panel, said she was impressed.

Hepatitis B, which is spread through body fluids, inflames the liver and can lead to liver scarring and even death; it can also cause liver cancer.

Some FDA panellists expressed some concerns for the pill, especially over the potential for cancer, as testing of the drug in mice and rats suggests a possible carcinogenic risk to humans, said drug researcher Lois Lehman-McKeeman. Continued monitoring for cancer and possible long-term resistance was recommended. The risks were not enough to warrant a black box warning. The FDA usually follows the advice of its advisory panels and is expected to make its decision by March 29.

The company plans to seek FDA approval in late-2005 and intends to conduct a post-marketing study over five to eight years to monitor risks.