Inferiority muddle

FDA’s Anti-Infective Drugs Advisory Committee last week agreed that non-inferiority can be used to assess drugs for nosocomial (hospital-acquired) pneumonia (NP; HAP). But the agency, clinicians and companies haven’t yet agreed on what to measure, which led the panel to render an ambivalent set of votes for Johnson & Johnson’s Doribax doripenem.

Despite voting 10-3 that the non-inferiority (NI) margin used by J&J in the Doribax trials was not justified, the committee voted 7-6 to recommend the antibiotic be approved to treat NP, including ventilator-associated pneumonia (VAP)...