September 2002 Cover
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The Food and Drug Administration's Antiviral Drugs Advisory Panel voted unanimously to recommend approval of a new drug for hepatitis B, a potentially life-threatening liver ailment that afflicts more than 1 million Americans. The drug, adefovir dipivoxil, is the latest payoff
from the nation's investment in AIDS research. It was originally developed for AIDS and then rejected because it damaged the kidneys, but it proved effective against hepatitis B in lower, and safer, doses.
FDA panel members said they remained concerned about the potential for kidney damage from the drug, and they called for careful monitoring in patients who use it, especially for long periods. But lower doses of the drug used in treating hepatitis tipped the balance of
risks and benefits in favor of adefovir. The FDA is not required to follow the recommendations of its advisory panels, but it usually does. Gilead Sciences said it hoped to market the drug by the end of the year.
Editor's Note: from the Washington Post
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