FDA Analysis of Antibiotic Development - with Hubris!

by David Shlaes  (contributor )   •     

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   Biopharma insight    # Clinical Trials   
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(This post originally appeared on David Shlaes's personal blog)
 
The US FDA just published an analysis of antibiotic development looking back over the last 40 years. The paper was accompanied by an editorial by Rex and Outterson. These papers are well worth reading and I highly recommend them for everyone whether they are familiar with antibiotic development or not. I must say that the hubris of the FDA analysis is astounding (see below). 
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The FDA paper documents and quantifies a number of facts most of us already know. 
  • Antibiotic discovery and development as gone from predominantly large pharma to almost all biotech.
  • The number of approvals of new antibiotics has drastically decreased in the last two decades (with a modest increase in recent years). 
  • The success in achieving market approval plummeted by 50%.
Two observations that were of high interest were that clinical development times have increased substantially and that the antibiotic classes being developed have changed to large percentage of classes outside of B-lactams, macrolides and quinolones. The FDA notes that there has been a recent increase in the number of B-lactamase inhibitors in development (a welcome change as far as I’m concerned), as well as an increase in “others.” I think that this may be related to the biotech nature of sponsors and their willingness to pursue non-traditional avenues such as peptides, peptidomimetics, new targets, etc. This also may help explain the lower success rates since, by definition, these may be higher risk ventures. 

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Topics: Clinical Trials   

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