- The Washington Times - Thursday, March 13, 2003

WASHINGTON, March 13 (UPI) — The Food and Drug Administration said Thursday it has approved the first in a new class of drugs for treating HIV/AIDS.

The drug, Fuzeon, prevents HIV from infecting cells and can be particularly beneficial to people with advanced AIDS who are failing on currently available drugs. Other AIDS medications act on HIV, the virus that causes AIDS, after it already has entered and infected cells.

"The accelerated approval of this new drug should provide new hope for those suffering from advanced HIV infection," said Health and Human Services Secretary Tommy Thompson.

Fuzeon is the first of a new class of medications called fusion inhibitors. The drugs prevent HIV from fusing with cell membranes, which blocks the ability of the virus to infect and destroy immune system cells.

"Fuzeon adds an important dimension to our armamentarium of anti-HIV treatments," said FDA Commissioner Dr. Mark McClellan. "By affecting viral spread in a different way from existing medications, it helps reduce viral loads, which has been shown to slow HIV progression in patients who have developed resistance to currently available medications," he said.

The drug was approved under FDA's accelerated approval process, which seeks to speed the availability of drugs that treat serious or life-threatening illnesses.

The decision to approve Fuzeon was based on two studies involving 1,000 patients who still had elevated HIV levels despite taking currently available AIDS medications. The studies showed the drug when used in conjunction with the other medications reduced the level of the virus in the blood significantly more than the other drugs alone.

The New England Journal of Medicine, which was scheduled to publish one of the studies in May, released it early to coincide with the FDA announcement.

"It's a very good day for people with HIV, particularly for those in trouble," Dr. Jacob P. Lalezari, of Quest Clinical Research in San Francisco and the lead author of the study, told United Press International.

Fuzeon "has been extremely potent as a new agent and I think it opens the door to a paradigm shift," Lalezari said. "Hopefully we'll be moving away from drugs … that work inside the cell and cause intracellular toxicity to a paradigm of drugs that prevent HIV from getting into the cells in the first place."

The drug, which is administered by injection twice daily, has been well-tolerated and adverse effects were minimal, Lalezari said. The main side effect of concern is a reaction at the injection site that consists of nodules that can last for hours to days, he said.

Other side effects include pneumonia, trouble breathing, fever and low blood pressure, according to the FDA. The long-term effects of the drug are unknown.

Because Fuzeon prevents HIV from infecting cells, it could also prove useful for treating people who know they have been exposed to the virus. "It is absolutely the drug you would want if you had an accidental needle exposure or potentially unsafe sex," Lalezari said.

Fuzeon will be available across the United States by the end of March with a price tag of about $20,000 per year, Heather Van Ness, spokeswoman for Hoffman-La Roche, the drug's manufacturer, told UPI.

The company — located in Nutley, N.J. — also is applying for regulatory approval of the drug in Switzerland, the European Union, Australia and Canada, Van Ness said.


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