New hepatitis B treatment approved in US
pharmafile | April 6, 2005 | News story | Sales and Marketing |
Bristol-Myers Squibb has received US approval for its hepatitis B treatment Baraclude after a six-month priority review.
Baraclude (entecavir) is BMS's fourth new drug approval in under two and half years and will be available in the US this month.
The drug was fast-tracked because of the potential advance it represents in a disease area with unmet medical needs. Analysts have consequently forecast sales in excess of $500 million.
The oral antiviral therapy is a once daily tablet and works by blocking the replication of hepatitis B virus (HBV) in the body by interfering with the virus' ability to infect cells.
The approval follows an FDA advisory committee conclusion that the drug had a superior efficacy to GSK's Zeffix (lamivudine), the most commonly prescribed oral antiviral therapy in the US.
Its recommendation was based on three 48-week studies involving 2,300 patients comparing the rival drugs. Patients treated with Baraclude showed a significant improvement in the liver inflammation caused by HBV and an improvement in the degree of liver fibrosis.
Baraclude and Zeffix showed similar safety profiles in the studies, with patients taking BMS's drug reporting headache, fatigue, diarrhoea and dyspepsia as the most common adverse reactions.
Hepatitis B is a potentially life-threatening disease, with more than half a million people dying worldwide each year from primary liver cancer, 80% of cases caused by chronic hepatitis B.
BMS has committed to carrying out a large post-marketing study of the treatment to evaluate the risks of cancer and liver related complications.
Baraclude is indicated for the treatment of chronic hepatitis B infection in adults with evidence of active viral replication who display evidence of persistent elevations in serum aminotransferases (ALT or ALS) or histologically active disease.
