A federal advisory committee recommended Tuesday that the first of a promising new class of anti-AIDS drugs be approved for use against advanced stages of the disease.
Despite concerns that the AIDS virus will adapt and become resistant to the drug, the Food and Drug Administration panel agreed that patients deserve accelerated access to the compound, called saquinavir.
The drug is the first of the class called protease inhibitors. These fight the virus by crippling a key enzyme it uses to reproduce.
The panel said saquinavir should be used only in combination with a drug such as AZT, which belongs to a class called nucleoside analogues. Studies suggest that the new drug is most effective when used with a nucleoside analogue the patient has never before taken. (The nucleoside drugs - including one recommended by the panel Monday called 3TC - interfere with the virus as it transcribes its genetic message into host cells.)
Saquinavir, which is made by Hoffmann-LaRoche, is not a cure for AIDS by any means, and definitive studies on its clinical value have not yet been completed. But the new class of drugs will offer patients another option for fighting the disease, researchers said.
Other companies, including Merck & Co., already are testing more potent protease inhibitors and are expected to seek FDA approval during the next year or so.
Tuesday, the panel expressed concern that the suggested dosage of saquinavir - 1,800 milligrams a day - might be too low. Some recent studies have shown a greater benefit using as much as a fourfold increase in dose. Accordingly, the panel recommended against using saquinavir alone at the current dose.
Advisory panel recommendations typically are followed by the FDA, and the agency’s boss spoke enthusiastically Tuesday about protease inhibitors.
“I strongly believe that, as a class, these are the most active agents we have seen to date,” said FDA Commissioner David Kessler. “The data we’ve seen say this drug in combination has a real effect. It’s a first step. It’s what we have available now.”
AIDS activists, while generally supporting the recommendations, said there are many unanswered questions about the drug. They are particularly concerned that the virus will become resistant not only to saquinavir but to more potent protease inhibitors yet to be approved.
They also raised questions about the cost of the drug, which they said could be as much as $6,000 a year. That would be added to the $2,000 a year patients typically must pay for AZT.
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