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The committee voted that 500 mg of DORIBAX at both the one-hour andfour-hour infusion regimens was safe (8-5) and effective (7-6). The committeedid not agree on the appropriate non-inferiority margins for anti-infectivestrials in nosocomial pneumonia.
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The independent Advisory Committee provides recommendations based on itsevaluation of the information presented. However, the final decision regardingapproval of the drug is made by the FDA.
"We recognize that there is an important need for new antibiotics to treatthese serious hospital infections," said Joanne Waldstreicher, M.D., GlobalHead, Drug Development, Johnson & Johnson Pharmaceutical Research &Development, L.L.C. "We look forward to further discussions with the FDA asthey complete their review of DORIBAX for the treatment of hospital-acquiredand ventilator-associated pneumonia."
DORIBAX is an intravenous (IV) antibiotic for hospital use, and belongs toa class of antibacterial drugs called carbapenems. Carbapenems are importantantibiotics to treat serious -- and sometimes life-threatening -- infectionscaused by a broad range of bacteria, which are characterized as Gram-negativeand Gram-positive, based on a classification process that is used to identifythe 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 byOrtho-McNeil, Division of Ortho-McNeil-Janssen Pharmaceuticals, Inc. The useof DORIBAX for the treatment of NP, including VAP, is under regulatory reviewin the U.S. DORIBAX received a positive opinion from the Committee forMedicinal Products for Human Use (CHMP) and is awaiting final approval inEurope for cIAI, cUTI and NP, including VAP. Doripenem is licensed fromShionogi & Co., Ltd.
INDICATIONS
DORIBAX is indicated as a single agent for the treatment of: complicatedintra-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 forthe treatment of complicated urinary tract infections, includingpyelonephritis, caused by susceptible strains of E. coli, including cases withconcurrent bacteremia, K. pneumoniae, P. mirabilis, P. aeruginosa, or A.baumannii.
To reduce the development of drug-resistant bacteria and maintain theeffectiveness of DORIBAX and other antibacterial drugs, DORIBAX should be usedonly to treat infections that are proven or strongly suspected to be caused bysusceptible bacteria. When culture and susceptibility information areavailable, they should be considered in selecting and modifying antibacterialtherapy. In the absence of such data, local epidemiology and susceptibilitypatterns may contribute to the empiric selection of therapy.
IMPORTANT SAFETY INFORMATION
DORIBAX is contraindicated in patients with known serious hypersensitivityto doripenem or other carbapenems or in patients who have demonstratedanaphylactic reactions to beta-lactams.
Serious and occasionally fatal hypersensitivity (anaphylactic) and seriousskin reactions have been reported in patients receiving beta-lactamantibiotics. These reactions are more likely to occur in individuals with ahistory of sensitivity to multiple allergens. If an allergic reaction toDORIBAX occurs, discontinue the dru
