The agency sent Johnson & Johnson and its partner, Basilea, a so-called complete response letter that mentions a bunch of problems, or what Basilea calls "specific deficiencies of study conduct." In other words, the FDA wants additional audits of clinical trial sites for Ceftobiprole, a broad-based spectrum antibiotic to treat the deadly MRSA superbug. What went wrong? There was a failure to ensure proper monitoring of the studies. And so the FDA wants info on clinical quality assurance programs and also asked for a new audit plan that addresses failures in monitoring by unnamed contract research organizations. In astatement, Basilea says the FDA is unable to review the clinical data until "issues of data integrity have been resolved."
Ceftobiprole is approved in Canada and Switzerland and has been recommended for approval in the European Union, but the US has been a different story. The FDA issued an approvable letter for the antibiotic last March because clinical data needed to be assessed. A new US application is planned within a year and European authorities have had no problems with the drug, Basilea ceo Anthony Man tells Reuters (Here is the J&J statement).