12:00 AM
Oct 22, 2001
 |  BioCentury  |  Regulation

Disarray over Xigris

Although Eli Lilly and Co.'s Xigris dorecogin alfa sepsis drug came under surprising and unanticipated criticism at its review by the Anti-Infective Drugs Advisory Committee last week, the FDA has given signs that it is unlikely to pay much attention to the final tally of votes in deciding whether to approve the sepsis compound by its Oct. 27 decision deadline.

Last week's panel meeting broke up in disarray, with the audience confused over how ambiguous votes would be tallied and the company baffled as to how it failed to get a robust endorsement of Xigris.

Moments after the meeting ended, LLY executives swarmed around Jay Siegal, director of the Office of Therapeutics Research and Review at CBER. They asked why issues that the agency indicated to the company were not problems ended up being key factors in several panelists' conclusions that there was insufficient data to demonstrate that Xigris is safe and effective to treat severe sepsis.

The LLY team also wanted to know how FDA would count the votes of participants who said they voted "yes and no" or that their vote was based on "a mental coin flip."

For the record, the committee's executive secretary, Thomas Perez, told BioCentury that the vote would be recorded as a 10-10 split, although he acknowledged that would require him to record two or three vague votes as favoring LLY.

FDA played down the significance of the vote as well as much of the deliberations, with Siegal making it clear after the meeting that FDA is more interested in the feedback the panel provided about specific questions than the precise vote count.

Going into the meeting, LLY (Indianapolis, Ind.).was confident it had pulled off a remarkable achievement, running the first clinical trial to show a statistically and clinically significant improvement in 28-day survival in severe...

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