A fascinating paper in the Annals of Internal Medicine, fittingly published in the lead up to the UN's High Level Meeting on Antimicrobial Resistance, is devoted to understanding how the fight against the pantheon of drug-resistant bacteria has went over the last 10 years. The scorecard being used is the number of antibiotics that the FDA approved between 2010-2015.
That number is 8.
While that number may seem to paint a rosy picture for our fight against superbugs, it really is not. While some members of the 8 have clearly had a major impact on the treatment of high priority drug resistant infections (e.g. ceftolozane-tazobactam, ceftazidime-avibactim, and bedaquiline), some have a limited role.
The summary statistics that are provided for the 8 provide important insight:
- 6 were developed outside of large pharmaceutical companies and now 7 are marketed by one of three major companies
- Only 1 drug showed superiority (as opposed to non-inferiority)
- The median time spent in clinical development was 6.2 years
- 7 of the 8 were from established drug classes
- Only 1 is indicated specifically for a drug resistant organism
- 3 of the 8 have activity against the high value targets known as the ESKAPE pathogens
There are a few implications that I draw from this very informative paper.
- Development of a new class of antibiotic is difficult
- The prospect of just having a drug indicated for resistant pathogens is one that is not so enticing financially and would require modification of clinical trials to include only those with drug-resistant pathogens
- Superiority in the absence of trials only using drug-resistant pathogens is difficult to prove as comparator drugs are also highly effective antibiotics
As the world's eyes turn to the fight against antimicrobial resistant bacteria, it is important to know where we stand and this paper provides an important glimpse of the frontlines of the battle.