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New AIDS drug wins FDA approval

Expensive drug first in new class of anti-HIV 'fusion inhibitors'

Expensive drug first in new class of anti-HIV 'fusion inhibitors'

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WASHINGTON (CNN) -- The Food and Drug Administration on Thursday announced approval of Fuzeon, the first new anti-HIV drug in years and the first in a new class of drugs called fusion inhibitors.

Unlike existing AIDS drugs, it blocks HIV before it enters the cell.

"Fuzeon adds an important dimension to our [methods] of anti-HIV treatments. 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," said FDA Commissioner Mark McClellan.

Fuzeon is administered as an injection twice a day and will be used in combination with other HIV drugs to treat advanced infection in adults and children over 6 years old.

Fuzeon is the first new class of AIDS treatment approved by the FDA in seven years. The drug's makers said it would be available by the end of the month.

But the drug will be expensive -- maker Roche Pharmaceuticals last month set a price of $20,000 a year, topping experts' estimated of $10,000 to $15,000.

In addition, the medication will come with a warning -- its label will advise doctors to carefully monitor patients for signs of pneumonia. During the trial, more patients using Fuzeon developed pneumonia than did those not using the drug. Fuzeon can also cause severe allergic reactions, and skin reactions at the injection site occurred in almost all patients.

Providing a 'lifeline'

The FDA granted Fuzeon priority review status six months ago, when data from Phase 3 clinical trials showed that its addition to combination therapies reduced the viral load -- the virus level in the bloodstream -- to undetectable levels, better than in those who took combination therapy without it.

Fusion inhibitors block the HIV virus' ability to attach itself onto cells. Current AIDS drugs combat the virus once it has already entered the cell.

"What this drug does for us is it provides a lifeline," said Dr. Calvin Cohen, the study's primary investigator. "There are many patients in trouble because the current drugs just aren't enough and aren't working well enough for them. This drug provides an anchor so that with Fuzeon and a new combination we can often reverse the course of HIV."

Co-developed by Roche and Trimeris, a biopharmaceutical company, the drug is expected to provide new hope to AIDS patients who have developed a resistance to existing medications.

"We believe it's very significant," said Dr. Dani Bolognesi, chief executive officer for Trimeris. "At the moment, the current drugs do not address the medical need that is out there and that is to effectively deal with virus that has become resistant to all of the classes of drugs that are there.

"Having a drug that does not differentiate between a virus which is multi-drug resistant or any other type of HIV is a new weapon for the physicians to use to optimize therapy in these patients."

According to the U.S. Centers for Disease Control and Prevention, an estimated 950,000 Americans are currently living with HIV. About 40,000 new HIV infections are reported each year.


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