Bristol-Myers Squibb files for approval of hepatitis B treatment

By admin

Originally published on October 05 2004 12:00 AM ET

Bristol-Myers Squibb on Monday announced the submission of a New Drug Application to the Food and Drug Administration for entecavir, an investigational antiviral agent under development for the treatment of chronic hepatitis B. A similar marketing application was filed with the European Medicines Evaluation Agency. Entecavir is an oral antiviral drug designed to selectively inhibit the hepatitis B virus by blocking all three steps in the viral replication process. A decision by the FDA may come as soon as next spring. Hepatitis A and B are sexually transmitted diseases that represent particular health risks for sexually active gay and bisexual men. The Gay and Lesbian Medical Association urges all gay men to be vaccinated against the viruses. Hepatitis B can lead to cirrhosis of the liver, liver cancer, and death. It's estimated that hepatitis B infects from 140,000 to 320,000 Americans each year, and 1.25 million have chronic hepatitis B infections.