Bristol-Myers Squibb has won the okay from the US Food and Drug Administration to market its new hepatitis B drug, Baraclude (entecavir).
The news comes just over a fortnight after the product secured the backing of an FDA advisory panel, which ruled that Baraclude was superior to other hepatitis B medicines [[14/03/05a]]. However, trial data did suggest a possible increased risk for cancer associated with the product’s use and, although the panel did not find that this was significant to warrant a “black box” warning – the strongest available – B-MS says it plans to conduct a post-marketing study to detect longer-term cancer risk in patients taking Baraclude.
The firm says that the drug will be available in the US as early as April 8, 2005 – just six months after it was originally filed with the US regulators [[05/10/04d]]. It is an oral drug designed to block all three steps in the virus’s replication process, and analysts have already suggested it could generate sales in excess of $500 million dollars.
Chronic hepatitis B infection is a potentially life-threatening disease. More than half a million people worldwide die each year from primary liver cancer, and up to 80% of primary liver cancers are caused by chronic hepatitis B. In the US, more than one million people have developed chronic hepatitis B infection and more than 5,000 Americans die from hepatitis B and hepatitis B-related liver complications each year.