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Ceftobiprole’s Long Road to Approval Gets Longer

Posted Jan 10 2010 9:16am

Cephalosporins with activity against MRSA are out there, but we don’t have them yet.  Just recently, the leader of the pack, ceftobiprole, hit another roadblock:

The FDA has indicated in its Complete Response Letter to Johnson & Johnson PRD that it has completed the review of the application and has determined that it cannot approve the application in its present form … The Agency determined that data from Studies BAP00154 and BAP00414 cannot be relied upon because inspections and audits of approximately one-third of the clinical trial sites for these studies found the data from a large proportion of these sites to be unreliable or unverifiable, raising concerns regarding the overall data integrity for both studies

The recommendation from the FDA?  Do more studies.  (Which means more delay, more $$$.)

One of the great frustrations of antibiotic development is that there’s clearly a need for better drugs for MRSA — unlike, say, a new PPI — yet this pipeline has been pretty dry.800px-MRSA7820

In fact, I bet not a day goes by in medical centers that this need is not readily apparent to ID doctors, surgeons, intensivists, pulmonologists, nephrologists (don’t dialysis patients seem to have the hardest time with MRSA?), endocrinologists (except maybe for people with diabetes), transplant specialists.  Pretty much everyone knows this bug is common and hard to treat.

If we start with the premise that vancomycin is the gold standard — and a fairly tarnished one at that — what are our alternatives?  Linezolid was a big advance (especially because it can be given orally), but it was approved ten years ago, is bacteriostatic, has certain unavoidable toxicity issues, and is costly, especially compared to other oral antibiotics.  Daptomycin was a somewhat smaller step forward, and I confess I still haven’t had the occasion to use telavancin.  Trimethoprim-sulfa and tetracyclines are active, but likely less so than vancomycin.

And ceftobiprole?  The initial application to the FDA was submitted in 2007; it is already approved in several other countries.  And while I have no idea whether the efficacy and safety of the drug will be preferable to what we have now — perhaps someone from Canada or Hong Kong or Europe can clue me in — just having more options for MRSA seems like a very good thing.

Ceftaroline/NXL104, anyone?

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