Since the reboot of
antibiotic development that the US Food and Drug Administration undertook
in mid-2012, there has been a clear acceleration in the rate of approvals of
new antibiotics. The graph below shows
FDA approvals of New Molecular Entities of antibiotics over time – and it
speaks for itself. Clearly, even after the reboot, we are not reaching the
rates of approval we saw during the 80s and 90s – the heyday of antibiotic
discovery and development. But there seems to be a clear improvement.
A close look at those approvals shows that two of the
antibiotics approved in 2014 (dalbavancin and oritavancin) were holdovers
discovered in the 90s that had previously been discontinued from development
related to changing FDA regulations, to market considerations and to technical
issues. Both are administered intravenously and target only Gram-positive
pathogens. Nevertheless, the post-2012 approval rate remains encouraging. Will
this continue?
I “borrowed” the analysis below from a public presentation
by John Rex describing the DRIVE-AB recommendations for pull incentives. Here
he analyzes the current pipeline focusing on resistant pathogens in terms of
WHO priorities and the likelihood of approval of products currently in
clinical trials. It looks like it is conceivable that today’s rate will
continue over the next five years but that new antibiotics active against
resistant strains of the gonococcus, Acinetobacter and Pseudomonas will remain
rare for the foreseeable future. The forecast is much more favorable for
antibiotics active against Enterobacteriaceae including those possessing extended
spectrum B-lactamases and those active against Gram-positive pathogens.
The WHO has concluded that this pipeline is insufficient to
meet our needs over the next decade and it is difficult to argue with that. Clearly, we need to stimulate additional
research – hence the need for both push and pull incentives.
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