J&J SUBMITS APPLICATION FOR CARBAPENEM ANTIBIOTIC

Johnson & Johnson (J&J) Pharmaceutical R&D has submitted a new drug application to the FDA for doripenem, an investigational carbapenem antibiotic, for the treatment of complicated intra-abdominal and complicated urinary tract infections.

Doripenem has demonstrated activity against a wide range of Gram-positive and Gram-negative bacteria including Pseudomonas. The drug belongs to a class of antibacterial agents called carbapenems, which are useful in treating life-threatening infections caused by Gram-positive and resistant Gram-negative bacteria, according to the company.

Pseudomonas, a Gram-negative bacterium, is one of the leading causes of resistant hospital-acquired infections for which treatment options are limited. The Centers for Disease Control and Prevention (CDC) and numerous other agencies and health organizations have identified antibiotic resistance as a serious threat to public health. The Infectious Disease Society of America estimates that approximately 2 million people acquire bacterial infections in U.S. hospitals each year. Of those 2 million patients, 90,000 people die as a result. The CDC estimates that approximately 70 percent of those fatal infections are resistant to at least one drug.

Upon regulatory approval, doripenem will be marketed in the United States by Ortho-McNeil. Doripenem is licensed from Shionogi.