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FDA Approves First of New Potent Anti-AIDS Drugs in Just 97 Days

By John Schwartz
The Washington Post
WASHINGTON

The Food and Drug Administration has approved the first of a potent new family of anti-AIDS drugs.

The new drug, saquinavir, belongs to a class of drugs called protease inhibitors. It was approved in just 97 days, reflecting the FDA's push for speedy approval of drugs for life-threatening illnesses such as AIDS.

"This is some of the most hopeful news in years for people living with AIDS," said Donna E. Shalala, secretary of the Department of Health and Human Services, in a statement.

All of the previously approved AIDS drugs are members of a group called nucleoside analogs, which work by interfering with the gene-replication cycle of HIV, the virus that causes AIDS. Protease inhibitors attack HIV at a later stage in its life cycle by blocking the action of an enzyme that virus particles use to cut a coat for themselves from the outer membrane of an infected cell.

The agency approved the new drug for use in combination with the older class of nucleoside analogs, since clinical trials showed that the one-two punch did more to suppress the activity of the virus than either type of drug alone. The effects of saquinavir are relatively long-lasting. When patients were given saquinavir in clinical trials, their counts of key immune cells known as CD4 lymphocytes rose and often remained elevated throughout the 16-week trial and sometimes for as long as a year, the FDA said.

Saquinavir, which is manufactured by Hoffman La Roche and will be sold under the brand name Invirase, did not perform as well in clinical trials as newer protease inhibitors made by other companies, apparently because it is poorly absorbed in the body. Roche is preparing a more effective form of the drug for review by the agency.

"It is important to make this drug available, because even in its present formulation it's an important weapon in the aresenal against AIDS," said FDA Commissioner David A. Kessler in an interview Thursday.

The cost to the pharmacist for a year's supply of the drug will be $5,800 per patient, and a drug industry analyst said the retail price could be as much as 20 percent higher. Gary Rose of the AIDS Action Council said he was worried that the cost of combination therapy with saquinavir and a nucleoside analog drug was prohibitive, coming to some $12,000 a year for basic antiviral therapy. "Who's going to pay for that?" he asked.

Kessler noted that each of the six currently licensed antiviral therapies against AIDS were approved in less than nine months. In almost every case, he said, the therapies were approved in the United States before comparable health agencies in the United Kingdom, France and Germany licensed them. Many American patients had access to the therapies even before approval under special FDA programs.