Oscient Pharmaceuticals was handed a convincing rejection in its push to expand the use of Factive to include acute bacterial sinusitis. An FDA advisory panel voted 10 to 4 that Oscient did not have sufficient data to demonstrate the efficacy of the drug and 11 to 2 that the drug did not present an "acceptable risk/benefit profile." The news knocked the company's share prices down 17.5 percent. The vote came after Oscient persuaded the FDA to drop one of the panel members after the developer claimed he had a conflict of interest. The FDA, of course, isn't bound by the vote. But regulators had questioned the safety of the drug going into the panel meeting and analysts aren't expecting an approval now. Factive is already approved for bronchitis and pneumonia.
- read the AP report on Factive
PLUS: Dr. Thomas Fleming, a prominent professor at the University of Washington, was asked to step aside from the advisory panel after Oscient complained to the FDA that he was already biased against one type of trial design used to gather data on Factive. Report