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Advisory Committee Votes in Favor of Efficacy, Safety Data for Doripenem for the Treatment of Hospital-Acquired Pneumonia
The committee voted that 500 mg of DORIBAX at both the one-hour and four-hour infusion regimens was safe (8-5) and effective (7-6). The committee 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. However, the final decision regarding approval of the drug is made by the FDA.
"We recognize that there is an important need for new antibiotics to treat these serious hospital infections," said Joanne Waldstreicher, M.D., Global Head, Drug Development, Johnson & Johnson Pharmaceutical Research & Development, L.L.C. "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 an intravenous (IV) antibiotic for hospital use, and belongs to a class of antibacterial drugs called carbapenems. Carbapenems are important antibiotics to treat serious -- and sometimes life-threatening -- infections caused by a broad range of bacteria, which are characterized as Gram-negative and Gram-positive, based on a classification process that is used to identify the specific type of bacteria.
DORIBAX is approved in the U.S. for the treatment of complicated intra- abdominal infections (cIAI) and complicated urinary tract infections (cUTI), including pyelonephritis, due to susceptible bacteria, and is marketed by Ortho-McNeil, Division of Ortho-McNeil-Janssen Pharmaceuticals, Inc. The use of DORIBAX for the treatment of NP, including VAP, is under regulatory review in the U.S. DORIBAX 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. Doripenem is licensed from Shionogi & Co., Ltd.
DORIBAX is indicated as a single agent for the treatment of: complicated intra-abdominal infections caused by susceptible strains of E. coli, K. pneumoniae, P. aeruginosa, B. caccae, B. fragilis, B. thetaiotaomicron, B. uniformis, B. vulgatus, S. intermedius, S. constellatus or P. micros, and for the treatment of complicated urinary tract infections, including pyelonephritis, caused by susceptible strains of E. coli, including cases with concurrent bacteremia, K. pneumoniae, P. mirabilis, P. aeruginosa, or A. baumannii.
To reduce the development of drug-resistant bacteria and maintain the effectiveness of DORIBAX and other antibacterial drugs, DORIBAX should be used only to treat infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting and modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.
Source: Johnson & Johnson Pharmaceutical Research & Development