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news.The FDA has approved Bristol-Myers Squibb's hepatitis B treatment Baraclude, sending the company's shares up over 2%. The drug will now be available in the US as early as April 8, 2005.
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Baraclude (entecavir) is indicated for the treatment of chronic hepatitis B infection in adults with evidence of active viral replication and either evidence of persistent elevations in serum aminotransferases or histologically active disease.
The Baraclude clinical trial program was the largest-ever conducted in chronic hepatitis B, and the first to compare two antivirals, Baraclude versus lamivudine (the most commonly used oral antiviral hepatitis B therapy). In these studies, after 48 weeks, Baraclude demonstrated statistically significant improvements compared to lamivudine, with a comparable safety profile.
“With the approval of Baraclude, Bristol-Myers Squibb will now be able to address another area of significant unmet medical need,” said Peter Dolan, chairman and CEO. “Baraclude represents the company’s fourth new pharmaceutical approved in less than two and a half years, and has the potential to help many adult patients with chronic hepatitis B infection.”
“With today’s FDA approval of Baraclude, physicians have an important new medication to treat chronic hepatitis B,” added said Dr Robert Gish, medical director of the California Pacific Medical Center’s liver transplant program.