22.02.10
CHMP rejects MAA of Basilea’s/J&J’s ceftobiprole
Basel – The EMA Committee for Medicinal Products for Human Use (CHMP) has rejected Basilea Pharmaceutica‘s Marketing Authorisation Application for ceftobiprole, intended for the treatment of complicated skin and soft tissue infections. This 5th generation cephalosporin antibiotic was seen as effective against methicillin-resistant S. aureus, penicillin-resistant S. pneumoniae, P. aeruginosa, and Enterococci, and had been shown to be statistically non-inferior to the combination of vancomycin and ceftazidime for the treatment of skin and soft tissue infections (more...). However, the CHMP stated that inspections showed that the registration phase III trials had not been conducted in compliance with GCP in some sites. The CHMP indicated that, although the study results suggested that the medicine was beneficial to patients, it was concerned about the reliability of results and in that light could not grant marketing authorisation. The MAA was originally filed by Basilea’s marketing partner Janssen-Cilag International, a Johnson & Johnson company, in June 2007. The CHMP initially gave a positive opinion in November 2008, however the EMA halted the European Commission authorisation process pending completion and assessment of Good Clinical Practice (GCP) inspections.