FDA Panel Unanimously Backs Drug Developed for HIV for Treatment of Hepatitis B
A 15-member FDA advisory panel on Tuesday unanimously endorsed Gilead Sciences' hepatitis B treatment adefovir for U.S. approval, the New York Times reports. The endorsement represents a "comeback" of sorts for the drug, which was originally developed as an HIV treatment but was rejected by the FDA in 1999 over concerns that the necessary high doses of the drug caused kidney damage. As a treatment for hepatitis B, adefovir is administered once a day in a much lower dose. However, some panel members expressed concern that kidney damage may occur in patients who use the drug longer than the participants of the 48-week clinical trials on which the recommendation is based (Pollack, New York Times, 8/7). To allay those fears, Gilead is conducting several longer-term studies of adefovir ( Bloomberg News/Los Angeles Times, 8/7). The FDA generally follows the recommendation of its advisory panels and has said it will issue a ruling on adefovir's approval by Sept. 21. Gilead CFO John Milligan said he expects to begin marketing the drug in the United States within three days of getting FDA approval (Abate, San Francisco Chronicle, 8/7).
During Tuesday's panel hearing, Gilead "won a surprising and unsought endorsement" from AIDS activist and playwright Larry Kramer, who is HIV- and hepatitis B-positive, the Wall Street Journal reports. Kramer underwent a liver transplant last year because of damage caused by hepatitis B, but said he considered delaying the transplant because his condition improved when taking adefovir (Hamilton, Wall Street Journal, 8/7). "I have paid my own expenses to appear before you today to testify on behalf of adefovir, which I consider to be a wonder drug and which I believe helped to save my life," Kramer, who founded the advocacy group ACT UP, said (Bloomberg News/Los Angeles Times, 8/7). He added that he is "not accustomed to appearing on behalf of any drug company" (Gillis, Washington Post, 8/7).