Johnson & Johnson submits NDA for antibiotic

The data supporting the NDA showed doripenem was an effective treatment for hospital-acquired, or nosocomial, 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, according to J&J. 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. 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% of these infections are resistant to at least one antibiotic. Pneumonia is the second, most-common, hospital-acquired infection in the US and is associated with substantial morbidity and mortality.