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AIDS DRUG APPROVED DESPITE INCOMPLETE DATA

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The Food and Drug Administration, saying many lives hang in the balance, approved a second AIDS drug Wednesday having less information than usually required about its long-term safety.

"There are still many unanswered questions," said Dr. Anthony Fauci, head of the National Institute on Allergy and Infectious Diseases.However, Fauci said studies testing the long-term safety and efficacy of didanosine, or DDI, are continuing.

"The overriding importance of today's action is that it offers a new means of defense against the AIDS virus, and thereby brings hope to those who cannot benefit from AZT," said FDA Commissioner David Kessler.

The drug was approved for use in treating patients at advanced stages of infection with AIDS who don't respond to or can't tolerate AZT, the only other fully approved anti-AIDS drug. Both drugs function similarly to slow progression of AIDS, but neither cures the disease.

Tests of the drug on AIDS patients showed that DDI can increase the number of white blood cells, called CD-4 cells, which have been shown to be important to immune system function, which is weakened with AIDS.

"We know this drug, DDI, affects CD-4 counts, and we know survival is tied to CD-4 counts," Kessler said. "There is somewhat of a leap there, but patients are dying and we think that extrapolation makes a lot of sense and is in patients' interests."

He said the FDA action also deviated from the norm because DDI was approved simultaneously for adults and children with AIDS. In the past, the agency has allowed use of a drug in adults before it has approved it for use in children.

The drug will be marketed by Bristol-Myers Squibb Co.