David's New Book

Thursday, June 27, 2013

A Few Updates


Apparently, the FDA is continuing in its effort to regulate fecal transplants for the treatment of Clostridium difficile diarrhea. I received an email from the IDSA stating that the FDA has announced that an emergency IND will be required to treat patients in this way. What a colossal waste of time and energy!  This will only delay the delivery of effective therapy to patients some of whom require treatment urgently. As I stated in my previous blog – what we need are clinical guidelines, not FDA regulation. 

As recommended by their advisory committee, the FDA has finally approved telavancin for use in nosocomial pneumonia based on exactly the same data used to reject Theravance’s application years earlier.  Further, they state that mortality in the telavancin arm was no different than that in the comparator arm.  So what? Ptients with nosocomial pneumonia frequently die of causes completely unrelated to their infection. Therefore, 28 day mortality is a futile endpoint in a non-inferiority study of nosocomial pneumonia as it drives everything towards the null.  I say this in spite of the retrospective data FDA has used to justify this endpoint.  See my previous writings on this topic.





Finally, BARDA has awarded Basilea, a European biotech, a grant that could be worth up to $89 million to develop its BAL30072 monosulfam antibiotic. This antibiotic has a very spotty spectrum.  Klebsiella are resistant while Acinetobacter are quite susceptible.  Nevertheless, BAL30072 is active against strains bearing metallo-B-lactamases since it is essentially a monobactam like aztreonam. BAL30072 might be a perfect candidate for a pathogen specific approach to clinical development as called for in LPAD.   Go BARDA!