A US Food and Drug Administration advisory committee has unanimously recommended approval of Bristol-Myers Squibb’s Baraclude (entecavir) in the first-line treatment of hepatitis B.
The panel agreed that Baraclude demonstrated superior efficacy and similar safety as GlaxoSmithKline’s Epivir (lamivudine) – the most commonly used oral antiviral therapy in the US – and ruled that this outweighed the possible risk for cancer associated with the product’s use. The maximum tolerated doses caused tumours in rodent studies, but the committee did not find that this potential risk was significant to warrant a “black box” warning – the strongest available. Nevertheless, B-MS says it plans to conduct a post-marketing study to detect longer-term cancer risk in patients taking Baraclude.
B-MS filed the drug with the US regulators back in September last year [[05/10/04d]], and was granted a six-month priority review status, which is awarded to products that could address an unmet medical need. 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 is a potentially life-threatening viral infection that may lead to cirrhosis, liver failure, and liver cancer. More than half a million people worldwide die each year from primary liver cancer, and up to 80% of liver cancers are caused by chronic hepatitis B. In the US, 12 million people, or one in every twenty, have been infected at some time in their lives with the hepatitis B virus, and more than five thousand die from hepatitis B-related liver complications each year.
