Important note: Information in this article was accurate in 1996. The state of the art may have changed since the publication date.
The Wall Street Journal - Monday, 25 November 1996
GAITHERSBURG, Md. -- A Food and Drug Administration advisory panel deadlocked on whether the agency should give accelerated approval to Pharmacia & Upjohn Inc.'s delavirdine, a treatment for adults infected with the AIDS virus.
The advisory panel's 4-4 vote apparently leaves the final decision up to the agency. FDA officials plan to meet with company representatives today to discuss the next step.
The tie vote followed an hours-long briefing during which the company released sketchy data and agency reviewers said they saw modest benefits. "I do feel that there is a need for this drug . . . [but] I don't think the data support accelerated approval," said Fred Valentine, a medical professor at New York University and a voting consultant on the FDA's Antiviral Drugs Advisory Committee. "As the standard of care becomes more effective, drug companies are going to have a harder time proving the effectiveness of their individual drug, particularly when used in combination with others."
Panel member Mary Dianne Murphy, chief of the Ambulatory Pediatric Services at the University of Florida-Jacksonville, said the drug should be recommended, although she, too, had problems with the data. "The problem is the inconsistency. We don't know where to use it, how to use it," Dr. Murphy said.
Other panel members said the drug should be approved because its side-effect and safety profiles were better than other medications already approved.
Company officials said they were disappointed with the split decision, but will wait to see what the agency has to say. If approved, delavirdine would become the 10th AIDS drug the FDA has cleared, and the second in a new class of drugs known as non-nucleoside reverse transcriptase inhibitors.
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