FDA issues complete response letter for Ceftobiprole for treatment of complicated skin infections

Johnson & Johnson Pharmaceutical Research & Development, L.L.C. (J&JPRD), has announced that it received a Complete Response letter from the U.S. 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.

The FDA has indicated that they cannot approve the NDA for ceftobiprole at this time. They have asked J&JPRD to conduct additional audit work of clinical investigator sites and to address specific questions related to site monitoring.

J&JPRD and its co-development partner, Swiss-based Basilea Pharmaceutica Ltd., are reviewing the Complete Response letter and will continue to work with the FDA to resolve questions that are outlined in the Complete Response letter.

The NDA for ceftobiprole was submitted to the FDA in May 2007, and, in March 2008, J&JPRD received an Approvable Letter regarding the ceftobiprole filing. J&JPRD responded to the FDA's Approvable Letter in August 2008.

Ceftobiprole was approved earlier this year in Canada, and most recently it was approved in Switzerland. Last week, the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency recommended approval of ceftobiprole in the European Union for the treatment of complicated skin and soft tissue infections.

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.

MRSA is a type of bacteria that is resistant to certain antibiotics. These antibiotics include methicillin and other more common antibiotics such as oxacillin, penicillin and amoxicillin. Staphylococcal (frequently called "Staph") infections, including MRSA, previously occurred most frequently among persons in hospitals and healthcare facilities who have weakened immune systems. Increasingly, cases are being reported in outpatient and community settings. These cases are referred to as community-associated MRSA (CA-MRSA) and are a growing healthcare concern.

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