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Johnson & Johnson Pharmaceutical Research & Development LLC announced today that the US Food and Drug Administration’s (FDA) Anti-Infective Drugs Advisory Committee voted in favour of the efficacy and safety data for Doribax (doripenem for injection) for the treatment of hospital-acquired pneumonia, or nosocomial pneumonia (NP), and ventilator-associated pneumonia (VAP).
The committee agreed that 500 mg of Doribax at both the one-hour and four-hour infusion regimens was safe (8-5) and effective (7-6), but did not agree on the appropriate non-inferiority margins for anti-infectives trials in nosocomial pneumonia.
The independent Advisory Committee provides recommendations based on its evaluation of the information presented, though the final decision regarding approval of the drug is made by the FDA itself.
“We recognise that there is an important need for new antibiotics to treat these serious hospital infections,” said Joanne Waldstreicher, MD, Global Head, Drug Development, Johnson & Johnson Pharmaceutical Research & Development LLC.
“We look forward to further discussions with the FDA as they complete their review of Doribax for the treatment of hospital-acquired and ventilator-associated pneumonia.”
Doribax is already approved in the US for the treatment of complicated intra-abdominal infections (cIAI) and complicated urinary tract infections (cUTI), including pyelonephritis, due to susceptible bacteria.
Doribax has already received a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) and is awaiting final approval in Europe for cIAI, cUTI and NP, including VAP.