Some interesting news just came out yesterday. It looks like J&J’s new anti-MRSA cephalosporin, ceftobiprole has been, once again, turned back by the FDA. See the story here:
http://money.cnn.com/news/newsfeeds/articles/marketwire/0572888.htm
Many of us had pretty high hopes for this antibiotic as it was to be the first cephalosporin active against MRSA. Although it is IV only, the idea of having a new MRSA agent that was in a class of drugs well liked and trusted by most, was appealing. It is also broad spectrum against a wide range of other Gram positive and Gram negative organisms. J&J even performed a clinical trial specifically looking at diabetic foot infections with promising results thus hoping to become only the 4th antibiotic (after linezolid, ertapenem and piperacillin/tazobactam) with that specific FDA indication. The drug was initially submitted for approval way back in 2007. The FDA sent an Approvable Letter questioning conduct at some of the study sites. The action taken yesterday by the Agency now seems to totally question the viability of the two pivotal trials. This may mean that entirely new studies would have to be completed thus delaying this drug for years more. It will be interesting to continue to watch this.
In the meantime, all is not lost for anti-MRSA cephalosporins. The drug most thought would be the late-comer to this party, ceftaroline, seems to be moving ahead. I will keep you all informed as I hear anything new.
I wish all of my readers a healthy, happy and prosperous, New Year
