Johnson & Johnson Pharmaceutical Research & Development, LLC (J&JPRD) received a Complete Response letter from the US Food and Drug Administration (FDA) for ceftobiprole. The New Drug Application (NDA) was originally submitted to the US FDA in May 2007 for the treatment of complicated skin and skin structure infections (cSSSI), including diabetic foot infections.
The US FDA has requested additional information and recommended additional clinical studies be conducted in order to consider a future approval of ceftobiprole in this indication. J&JPRD intends to discuss the best path forward with the US FDA as soon as possible.
Ceftobiprole was licensed from Swiss-based Basilea Pharmaceutica Ltd. in February 2005. In March 2008, J&JPRD received an Approvable Letter regarding the ceftobiprole filing. J&JPRD responded to the US FDA’s Approvable Letter in August 2008. In November 2008, J&JPRD received a Complete Response letter, which recommended additional site audits be conducted. The company completed those audits through a third party and included the results in its June 2009 response to the FDA’s Complete Response letter.
Ceftobiprole is a novel, broad-spectrum, anti-MRSA cephalosporin with activity against methicillin-resistant Staphylococcus aureus (MRSA), penicillin-resistant Streptococcus pneumonia and many clinically important Gram-negative bacteria, including Pseudomonas.