Important note: Information in this article was accurate in 2002. The state of the art may have changed since the publication date.
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Wall Street Journal - August 7, 2002
David P. Hamilton, Staff Reporter of The Wall Street Journal
The vote in favor of the drug, known as adefovir dipivoxil, isn't binding on the FDA, although the agency generally follows the advice of its independent experts. It's also the second major piece of news for Gilead, Foster City, Calif., in the last year.
Last October, the FDA approved the company's related treatment for AIDS, brand-named Viread and known generically as tenofovir, which has sold well initially.
The panel's decision is also a turnaround for adefovir itself, which Gilead had initially submitted to the FDA as an AIDS drug several years ago. While it showed some effectiveness against the AIDS virus, an advisory panel recommended against approval in late 1999 because of fears that it led to kidney damage.
Both Viread and adefovir are the latest examples of a class of antiviral drugs that work by blocking the ability of viruses to reproduce inside human cells. Known technically as nucleotide analogues, the drugs both mimic basic units of DNA known as nucleotides, the "letters" that make up the genetic code.
At the panel meeting, Gilead won a surprising and unsought endorsement from irascible AIDS activist Larry Kramer, who called adefovir a "wonder drug." Mr. Kramer, who believes he has been HIV-positive and infected with hepatitis B for more than two decades, said he had considered delaying a hepatitis-related liver transplant once his condition improved on adefovir.
Hepatitis B is a serious problem around the world, where one in three people have been infected at some point and roughly 400 million people remain chronic carriers of the virus, according to the Hepatitis B Foundation. Still, some analysts believe that adefovir faces difficult challenges, in particular in terms of marketing and sales in the Third World.
Earlier this year, in fact, Gilead licensed adefovir rights for Asia, Latin America and other areas to GlaxoSmithKline PLC, which makes another hepatitis B drug called lamivudine. Analysts say lamivudine, also a successful AIDS drug, hasn't been the hit against hepatitis B that they expected. Should adefovir be approved, however, doctors may begin prescribing it together with lamivudine, much the way AIDS is now treated with several antiviral drugs in combination.
Write to David P. Hamilton at david.hamilton@wsj.com
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