European decision also on hold as a result of ongoing GCP inspection.
FDA issued Johnson & Johnson Pharmaceutical Research and Development (J&JPRD) a warning letter relating to its conduct of clinical trials with the broad-spectrum anti-MRSA cephalosporin antibiotic, ceftobiprole (Zeftera™/Zevtera™). J&JPRD is developing the drug under an exclusive, worldwide license from Basilea Pharmceutica, which it obtained in 2005.
FDA’s rap on the knuckles comes just six months after Basilea confirmed that the EMEA told J&JPRD it was halting its review process for ceftobiprole, pending completion of GCP inspections. The European agency’s Committee for Medicinal Products for Human Use (CHMP) had given the drug a positive benefit-risk opinion and recommendation for European approval just two months prior. Basilea anticipates the final report from the EMEA GCP inspections will be available to the CHMP in the second half of this year.
The new FDA warning letter noted a failure on J&JPRD’s part relating to both proper monitoring of studies and deficiencies in study conduct. J&JPRD has 15 days from receipt of the letter to notify FDA in writing of restorative actions. The agency confirmed regulatory action may otherwise be effected without notice.
Deficiencies noted by FDA included: failure to ensure proper monitoring of the clinical investigations, failure to ensure that an investigation was conducted in accordance with the general investigational plan and protocols as specified in the IND, failure to secure investigator compliance with the investigational plan and applicable FDA regulations, as well as failure to ensure that only investigators who were qualified by training and experience were selected as appropriate experts to investigate a drug.
Ceftobiprole has been approved and is marketed in Canada (Zeftera™) and Swizerland (Zevtera) for the treatment of complicated skin and skin structure infections (cSSSI) including nonlimb threatening diabetic foot infections without concomitant osteomyelitis. Marketing applications for ceftobiprole have been submitted in the U.S., the EU, and several other countries. The antibiotic is also in Phase III development for the treatment of nosocomial pneumonia and hospitalized community-acquired pneumonia. Basilea has exercised its option to co-promote ceftobiprole in North America and major European markets and retains a co-promotion option in Japan and China.