BioCentury
ARTICLE | Clinical News

Doribax regulatory update

July 2, 2012 7:00 AM UTC

EMA's CHMP recommended updating the label for Doribax doripenem to include higher dosage of the antibiotic in patients with nosocomial pneumonia, including ventilator-associated pneumonia (VAP). Specifically, CHMP recommended physicians double the dose to 1 g Doribax every 8 hours in patients with augmented renal clearance and/or with infections with non-fermenting Gram-negative pathogens, and advised that a longer treatment period of 10-14 days is required in nosocomial pneumonia patients. The approved dose is 500 mg every 8 hours for up to 14 days. The committee also said physicians should exercise caution in patients for whom non-fermenting, Gram-negative pathogens such as Pseudomonas aeruginosa and Acinetobacter are suspected or confirmed as the cause of infection, and that concomitant treatment with an aminoglycoside antibiotic should be initiated in some of these patients.

The recommendations follow a review of Doribax that began after the an IDMC recommended stopping a double-blind, international Phase III trial comparing a 7-day course of 1 g Doribax vs. a 10-day course of 1 g imipenem/cilastatin in VAP patients because those in the Doribax arm were less likely to recover than patients in the comparator arm (see BioCentury, Jan. 16). ...