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!
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