Important note: Information in this article was accurate in 1996. The state of the art may have changed since the publication date.
The Associated Press - Saturday, 23 November 1996.
Anita Womack, Associated Press Writer
Agency reviewers said one study showed no clinical benefit, but late CD4 effects were seen in another study which could not be duplicated in a third.
Agency researchers say they also determined that delavirdine caused vasculitis affecting coronary arteries in dogs and monkeys. Delavirdine also caused fetal toxicity.
Delavirdine also was administered to several pregnant women and officials said the drug caused one infant to be born with ventricular setpal defect. Another woman miscarried, while the third infant was born normal. FDA officials suggested that the drug be labeled as a category three with little conclusive data of its effect on women and children.
Agency reviewers also said that patients in the studies who were taking delavirdine were more likely to discontinue use than others.
Many AIDS activists testified that they support accelerated approval of Pharmacia & Upjohn's delavirdine, but many of them admitted they are doing so reluctantly because of the lack of strong data presented by the company. Accelerated approval of new drugs is intended to determine the safety and efficacy in treating serious or life-threatening illness which shows therapeutic benefit to patients over existing treatment.
"We support accelerated approval," said Jules Levin of National AIDS Treatment Advocacy Project of New York City. "We should have had more data sooner. I consider this very preliminary data."
This is the fourth anti-HIV drug to be considered for approval by the committee since February. Last year, the FDA approved two new antiretroviral therapies.
Rescriptor tablets have been studied in combination with other AIDS treatments: zidovudine (AZT), didanosine (ddI), zalcitabine (ddC), lamivudine (3TC) and stavudine (d4T).
Other AIDS activists said benefit was evident in triple combination, but not in double combination, and asked how the advisory panel would handle such a labeling if that was to be communicated to the public.
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