WASHINGTON, March 13 (AFP) - US drug authorities on Thursday approved the first in a new class of medications to fight HIV by preventing the virus from entering the immune system's cells.
The US Food and Drug Administration gave its approval to the medicine, known as T20 but to be marketed under the name Fuzeon, which patients would take in combination with other drugs already used to fight HIV in children and adults.
Fuzeon belongs to a new class of drugs known as "fusion inhibitors," which work by preventing the AIDS virus from entering cells.
Existing drugs fight the virus after it has already infected the immune system's cells.
"The accelerated approval of this new drug should provide new hope for those suffering from advanced HIV infection," Health and Human Services Secretary Tommy Thompson said.
The FDA approved the drug under a scheme designed to grant speedy authorization for sales of drugs to people with serious or life-threatening illnesses.
"Fuzeon adds an important dimension to our armamentarium of anti-HIV treatments," FDA chief Mark McClellan said.
"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 United States is the first country to approve the drug for sale. An estimated 850,000 to 900,000 Americans have HIV, with 40,000 new infections a year, according to the Centers for Disease Control and Prevention.
Many HIV patients carry a form of the virus resistant to existing medications.
Doctors at the International AIDS conference in Madrid last year rated the molecule contained in Fuzeon as one of the biggest innovations in the battle to treat HIV since the emergence of anti-retrovirals in the 1990s.
The molecule, a so-called fusion inhibitor named enfuvirtide, enabled patients to recover from an immune system that had been almost wrecked by sky-high levels of the human immunodeficiency virus (HIV) in their blood and a rock-bottom level of CD4 immune cells.
The FDA decision prompted the New England Journal of Medicine to issue an early release of a study set for publication on May 29, documenting the drug's effectiveness in patients who had become resistant to existing drugs.
The drug is administered by injection. About 1,000 patients underwent trials in North America, Brazil, Europe and Australia.
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