J&J submits MAA for doripenem to EMEA

Belgium's Janssen-Cilag International NV, a unit of US health care major Johnson & Johnson, says that the European Medicines Agency (EMEA) has accepted for review a Marketing Authorization Application for its investigational antibiotic doripenem for the treatment of nosocomial pneumonia, including ventilator-associated pneumonia, complicated intra-abdominal infections and complicated urinary tract infections.

According to the European Commission, health care-associated infections affect an estimated one in 10 patients, leading to a considerable increase in suffering, cost and mortality, with approximately 50,000 patients dying each year as a result. Urinary tract infections and pneumonia are the two most commonly occurring health care-associated infections in Europe.

Doripenem belongs to the carbapenem class of antibacterials, which are useful in treating life-threatening infections caused by Gram-negative and Gram-positive bacteria. The data supporting the MAA demonstrated the effectiveness of doripenem against infections caused by Gram-negative bacteria, such as Pseudomonas aeruginosa and Enterobacteriaceae, including strains of these bacteria that are resistant to other therapies. In general, there are few antibiotics available or currently in development to treat the resistant and potentially life-threatening infections associated with these Gram-negative bacteria, J&J noted. Following regulatory approval, doripenem will be marketed in Europe by the Janssen-Cilag companies. The agent is licensed from its originator, Japan's Shionogi, which launched the product on its domestic market in September 2005.