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Breakthrough AIDS Drug Gets FDA Nod

Fuzeon Works When Other Drugs Fail -- Extreme Cost an Issue
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March 13, 2003 -- The FDA today approved Fuzeon, the first of a new class of AIDS drugs. The drug fights HIV when all other treatments fail.

In Europe, where Fuzeon already is approved, the drug carries a breathtaking price tag -- about $20,500 per year. The U.S. price is expected to be about the same. That's nearly three times the price of the next-most-expensive AIDS drug. State programs to supply AIDS drugs to patients who can't afford them -- and who would die without them -- already are running out of money.

But Fuzeon is not like other drugs, says Heather Van Ness, spokeswoman for Hoffman-La Roche Pharmaceuticals, which is developing the drug with Trimeris Inc.

"The complexity of this drug is unprecedented," Van Ness tells WebMD. "This molecule is many times larger than other anti-HIV molecules. It is the most complicated manufacturing process ever instituted on a large scale. It takes 106 steps, not the five or six steps needed to make most other AIDS drugs. It takes 45,000 kilograms of expensive raw materials to make 1,000 kilograms of Fuzeon."

FDA approval follows the February 2003 announcement of a clinical trial showing that Fuzeon works in patients for whom other AIDS drugs have failed. In these most-difficult-to-treat patients, Fuzeon provided significant benefit for at least 24 weeks. The study findings will appear in the May 29, 2003 issue of TheNew England Journal of Medicine. Following FDA approval, NEJM made the paper available on the Internet.

It's a major medical advance, according to AIDS researcher Michael Saag, MD, director of the AIDS outpatient clinic at the University of Alabama, Birmingham.

"This new fusion inhibitor is a significant breakthrough and its approval is a milestone event in the HIV epidemic," Saag says in a Roche news release. "Patients are becoming resistant to our best therapies and they need new options. This drug attacks the virus in a new way, so it can work for patients whose virus is resistant to other therapies."

All other AIDS drugs fight the HIV after it's infected human cells. But fusion inhibitors -- of which Fuzeon is the first -- keep the AIDS virus from getting into cells in the first place. Other new fusion inhibitors, which work in different ways, are in earlier stages of development.

Fuzeon isn't easy to take. It has to be given by two daily injections. Roche and Trimeris are developing a second-generation fusion inhibitor of the drug, dubbed T-1249. It's now in early clinical tests.

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