Gilead Hepatitis Drug Wins FDA Panel’s OK

Gilead Sciences Inc.’s adefovir drug for hepatitis B won the backing of a Food and Drug Administration expert panel Tuesday.

The advisory committee voted 15 to 0 to recommend that the FDA approve the medicine to treat the viral infection that may cause liver damage and death.

Some panel members raised questions about whether patients on adefovir should be monitored for signs of liver and kidney damage. Gilead said it is conducting more long-term studies of adefovir after the studies submitted to the FDA, which lasted almost a year.

The FDA usually accepts the recommendations of its advisory panels.

About 1.3 million people in the U.S. have chronic hepatitis B infections, according to the U.S. Centers for Disease Control and Prevention. In some cases, patients with the disease die of chronic liver disease or require liver transplants.

Adefovir suppresses the virus that causes hepatitis B more effectively than GlaxoSmithKline’s widely used Epivir, Gilead told the panel.

Epivir often loses its ability to fight the virus over time, leaving patients without an effective drug to control the virus, doctors say. Foster City, Calif.-based Gilead said it is studying the use of adefovir combined with Epivir.

Adefovir already has wide support among hepatitis B patients, including AIDS activist and playwright Larry Kramer.

Kramer, who underwent liver-transplant surgery because of hepatitis B, takes adefovir to keep the virus in check. Founder of the AIDS activist group ACT UP, he said he has long been a critic of drug makers.

“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 said.

Analysts estimate that adefovir could garner annual sales of $100 million to $200 million within a few years.

Gilead won U.S. approval in October for its Viread AIDS treatment. The company’s successes with the FDA stand in contrast to setbacks for rival biotechnology companies and drug makers seeking U.S. approval of medicines.

Trading in Gilead shares was halted during the FDA panel hearing.