This entry is based on the following paper:
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📄 Outterson K, Orubu ESF, Rex J, Årdal C, Zaman MH. Patient Access in 14 High-Income Countries to New Antibacterials Approved by the US Food and Drug Administration, European Medicines Agency, Japanese Pharmaceuticals and Medical Devices Agency, or Health Canada, 2010-2020. Clin Infect Dis. 2022 Apr 9;74(7):1183-1190. doi: 10.1093/cid/ciab612. PMID: 34251436; PMCID: PMC8994582.
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The reason this is important
Evolution of carbapenemases alongside carbapenems:
Taken from this tweet here.
AMR is a rising problem in LMICs, and is disproportionately (~70%) related to beta lactams and quinolones.
Availability of new antimicrobials
Taken from this tweet from @bradspellberg:
NB: Green = meets unmet need; Yellow = sorta maybe has some use; Red = does not address unmet need
So: So in summary we have since 2009 approved the following:
-
Gram positive (MRSA, VRE etc):
- Tela/Dalba/Oritavancin
- Ceftaroline/Ceftobiprole
- Tedizolid
- Delafloxacin
- Omadacycline
- Lefamulin
-
TB (not discussed further)
-
Gram negative (ESBL, CRE):
- Beta-lactam +/- BLI:
- Pseudomonas: Ceftolozane-Tazobactam, ?Ceftobiprole?
- CRAB: Sulbactam-durlobactam
- Ceftazidime-avibactam
- Meropenem-vaborbactam
- Imipenem-cilastatin-relebactam
- Cefepime-enmetazobactam
- Cefiderocol THE TROJAN HORSE
- Non-beta lactams:
So for G+ we have:
- 3 long-acting glycopeptides
- 2 beta-lactams
- A linezolid clone, a quinolone, a tetracycline & a pleuromutilin (google it)
And for G- we have:
- 1 Beta lactam
- 7 BL/BLIs
- 1 trojan horse
- A tetracycline & an aminoglycoside.
So who can access these antibiotics?
Figure 1 from the above paper:
Country: of 18 drugs approved worldwide:
- 17 available in US (Lascufloxacin only launched in Japan)
- 14 in EU (No Lascufloxacin, Omadacycline, Sarecycline, Plazomicin)
- 11 UK (as per EU, plus no Lefamulin, Eravacycline, Oritavancin)
- Of the other G7 countries:
- France has access to 8
- Italy & Germany: 7
- Japan: 5
- Canada: 2! (Ceftolozane-tazobactam, Fidaxomicin)
Drug: Availability out of 14 countries studied:
- Available in 14: Fidaxomicin, Ceftolozane-tazobactam
- 12: Ceftaroline, Tedizolid, Ceftazidime/avibactam
- 10: Dalbavancin
- 9: Bezlotuximab
- 2-9: Cefiderocol, Imipenem/relebactam, Meropenem/vaborbactam, Delafloxacin
- 1: Lascufloxacin (Japan), Lefamulin, Omadacycline, Seracycline, Eravacycline, Plazomicin, Oritavancin
Note re: the 4 drugs not approved in the EMA: