The Committee for Medicinal Products for Human Use (CHMP) has recommended approval for the antibiotic, Doribax (doripenem) as a treatment for nosocomial pneumonia (NP), including ventilator-associated pneumonia (VAP), complicated intra-abdominal (cIAI) and complicated urinary tract infections (cUTI).
It is expected that the European Commission will grant final approval to market Doribax in the European Union later this year.
Doripenem is a broad-spectrum, intravenous (IV) carbapenem for hospital use. It has potent activity against a wide range of gram-negative, gram-positive and anaerobic pathogens including Pseudomonas aeruginosa, Acinetobacter and Enterobacteriaceae. These are some of the major organisms associated with nosocomial pneumonia.
Specifically, Doribax has demonstrated a lower potential to select for in-vitro resistance against Pseudomonas aeruginosa. This potent in-vitro activity of Doribax against common VAP pathogens was confirmed by demonstration of clinical efficacy in VAP patients in two pivotal clinical trials.
Doripenem is stable after reconstitution, which allows for the flexibility to extend the infusion time from one hour to four hours to treat more seriously ill patients. The most common adverse reactions reported for Doribax were headache, nausea, diarrhoea, rash, and phlebitis. In addition, allergic reactions have occurred and some patients may require immediate treatment. Although seizures are known to be associated with other carbapenems, in six, large, phase III clinical trials, there were no confirmed drug-related seizures with Doribax.
Doribax is currently approved for the treatment of cUTI and cIAI in the USA.