Johnson & Johnson Pharmaceutical Research & Development, L.L.C., (J&JPRD) announced that it has submitted a New Drug Application (NDA) to the United States Food and Drug Administration (FDA) for doripenem, an investigational carbapenem antibiotic for the treatment of nosocomial pneumonia, a pneumonia that is acquired in a hospital or other healthcare setting.
According to the Centers for Disease Control and Prevention (CDC), two million Americans develop hospital-acquired infections each year, and approximately 90,000 die as a result. Approximately 70 percent of these infections are resistant to at least one antibiotic. Pneumonia is the second, most-common, hospital-acquired infection in the United States and is associated with substantial morbidity and mortality.
Doripenem belongs to a class of antibacterial agents called carbapenems, which are useful in treating life-threatening infections caused by Gram-negative1 and Gram-positive2 bacteria. The data supporting the NDA showed doripenem was an effective treatment for hospital-acquired pneumonia. The data also 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.
Pseudomonas aeruginosa is one of the leading causes of hospital-acquired infections and, because of increasing multi-drug resistance, treatment options are limited. In general, there are few antibiotics available or currently in development to treat the resistant infections – which can be potentially life-threatening – associated with these Gram-negative bacteria.
In clinical trials, doripenem was well-tolerated. The most common treatment-emergent adverse events seen were diarrhea, nausea, constipation, urinary tract infection and decubitus ulcer, commonly known as a bedsore.
The nosocomial pneumonia indication for doripenem had been granted “fast-track” status by the FDA. An NDA for the treatment of complicated intra-abdominal and complicated urinary tract infections was submitted to the FDA in December 2006. These submissions demonstrate the ongoing commitment of J&JPRD and its affiliate, Ortho-McNeil, Inc., to developing novel drugs for the anti-infective market. Pending regulatory approval, doripenem will be marketed in the United States by Ortho-McNeil, Inc. Doripenem is licensed from Shionogi & Co., Ltd., which launched the product in Japan in September 2005.