US FDA's non-inferiority stance could slow sinusitis approvals

摘要

The US FDA's review of Oscient's quinolone Factive (gemifloxacin mesylate) should make other antibiotic drug sponsors wary of relying on non-inferiority studies to support approval for acute bacterial sinusitis (ABS).puring last week's anti-infective drugs advisory panel meeting, the FDA said Factive's efficacy should be evaluated in light of the evolving science favouring superiority or placebo-controlled trials over non-inferiority studies in sinusitis. The panel recommended against approval of Factive in ABS (Scrip No 3192, p 21).