Review committee questioned in particular the noninferiority margin.
Johnson & Johnson Pharmaceutical Research & Development (J&JPRD) reports that the FDA requires additional data to approve Doribax™ for hospital-acquired pneumonia, or nosocomial pneumonia (NP), including ventilator-associated pneumonia (VAP).
In its complete response letter, the FDA’s Anti-Infective Drugs Advisory Committee noted that members did not agree that the noninferiority margin for the Doribax NP trials was appropriately justified. They also disagreed on the appropriate margin for NP trials in general.
Doribax did, however, garner a majority vote in favor of safety and effectiveness for the 500 mg dose at the one-hour and four-hour infusion regimens. Eight out of thirteen members voted in favor of safety data and seven voted in favor of the drug’s effectiveness.
The NDA for Doribax for the treatment of NP including VAP was submitted in June 2007. The drug is already indicated for complicated intra-abdominal infections (cIAI) and complicated urinary tract infections (cUTI) including pyelonephritis due to susceptible bacteria. Doribax is approved in Europe and Russia for cIAI, cUTI, and NP including VAP.