Johnson and Johnson Pharmaceutical Research and Development, L.L.C. (J&JPRD), has received an approvable letter from the US Food and Drug Administration (FDA) regarding its New Drug Application (NDA) for ceftobiprole for the treatment of complicated skin and skin structure infections, including diabetic foot infections.

J&JPRD, along with its co-development partner, Swiss-based Basilea Pharmaceutica Ltd., is reviewing the agency's letter and will work quickly to resolve any outstanding issues. The NDA for ceftobiprole was submitted to the FDA last May.

Dr. Anthony Man, CEO, Basilea said, "We are closely working together with our development partner Johnson & Johnson Pharmaceutical Research and Development, L.L.C., to quickly address the questions from the FDA."


An application for the use of ceftobiprole in adults in the same indication is currently under regulatory review in Europe, Australia, Canada and in other countries.

The NDA submission of ceftobiprole for the treatment of complicated skin and skin structure infections includes the data from two pivotal phase III trials (STRAUSS 1 and STRAUSS 2). These trials comprise data from over 1600 patients including those with diabetic foot infections caused by Gram-negative and Gram-positive pathogens and with methicillin-resistant Staphylococcus aureus (MRSA) infections. In both of these large, multinational, double-blind, randomized phase III clinical studies, ceftobiprole was effective, demonstrated by achievement of the non-inferiority endpoint to single drug or two-drug combination comparators, respectively. Ceftobiprole was well tolerated with a safety profile consistent with the cephalosporin class of antibiotics.

J&JPRD, a part of Johnson & Johnson, has facilities throughout Asia, Europe and the United States. J&JPRD is leveraging drug discovery and drug development in a variety of therapeutic areas to address unmet medical needs worldwide.