TABLE 2.
Antibacterial drugs that gained market authorization between July 2017 and June 2021a
| Name (trade name) | Market authorization holder(s) | Agency/agencies granting approval (date) | Antibacterial class | Route of administration | Indication(s) | WHO EML & AWaRe | Expected activity against priority pathogensb |
Innovationc |
||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| CRAB | CRPA | CRE | OPP | NCR | CC | T | MoA | |||||||
| Delafloxacin (Baxdela) | Melinta (Menarini, EU) | FDA (6/2017 ABSSSI, 10/2019 CAP), EMA (12/2019 ABSSSI) | Fluoroquinolone | i.v. & oral | ABSSSI, CAP | AWaRe: Watch | ○ | ○ | ○ | ● | — | — | — | — |
| Vaborbactam + meropenem (Vabomere) | Melinta (Menarini, EU) | FDA (8/2017), EMA (11/2018) | Boronate BLI + β-lactam (carbapenem) | i.v. | cUTI | WHO EML & AWaRe: Reserve | ○ | ○ | ●d | NA | ?e | ✓ | — | — |
| Plazomicin (Zemdri) | Achaogen (Cipla USA / QiLu Antibiotics, China) | FDA (8/2018) | Aminoglycoside | i.v. | cUTI | WHO EML & AWaRe: Reserve | ○ | ○ | ● | NA | — | — | — | — |
| Eravacycline (Xerava) | Tetraphase (La Jolla, Everest Medicines) | FDA (8/2018), EMA (9/2018) | Tetracycline | i.v. | cIAI | AWaRe: Reserve | ? | ○ | ● | NA | — | — | — | — |
| Omadacycline (Nuzyra) | Paratek | FDA (10/2018) | Tetracycline | i.v. & oral | CAP (iv), ABSSSI (iv, oral) | AWaRe: Reserve | ○ | ○ | ○ | ● | — | — | — | — |
| Relebactam + imipenem/cilastatin (Recarbrio) | MSD | FDA (7/2019 cUTI/cIAI, 7/2020 HAP/VAP), EMA (2/2020 Gram -ve) | DBO-BLI + β-lactam (carbapenem)/ degradation inhibitor | i.v. | cUTI, cIAI, HAP/VAP | AWaRe: Reserve | ○ | ? | ●d | NA | — | — | — | — |
| Lefamulin (Xenleta) | Nabriva (Sunovion Pharmaceuticals Canada) | FDA (8/2019), EMA (7/2020) | Pleuromutilin | i.v. & oral | CAP | AWaRe: Reserve | NA | NA | NA | ● | ? | ✓f | — | — |
| Pretomanid (Dovprela) | Viatris (TB Alliance)g | FDA (8/2019), EMA (8/2020), CDSCO (7/2020) | Nitroimidazole | Oral | XDR-TB | NA | NA | NA | ●h | — | — | — | — | |
| Lascufloxacin (Lasvic) | Kyorin Pharmaceutical | PDMA (8/2019) | Fluoroquinolone | i.v. & oral | CAP, otorhinolaryngological | AWaRe: Watch | ○ | ○ | ○ | ● | — | — | — | — |
| Cefiderocol (Fetroja) | Shionogi | FDA (11/2019, cUTI; 9/21 HAP/VAP), EMA (4/2020) | Siderophore β-lactam (cephalosporin) | i.v. | FDA: cUTI, HAP/VAP, EMA: aerobic G-ve | WHO EML & AwaRe: Reserve | ● | ● | ● | NA | ? | — | — | — |
| Levonadifloxacin (Emrok), Alalevonadifloxacin (Emrok-O) | Wockhardt | CDSCO (1/2020) | Fluoroquinolone | i.v. & oral | ABSSSI | AwaRe: Watch | ○ | ○ | ○ | ● | — | — | — | — |
| Contezolid (Youxitai), Contezolid acefosamil | MicuRx | NMPA (6/2021) | Oxazolidinone | i.v. & oral | cSSTI | NA | NA | NA | ● | — | — | — | — | |
Abbreviations: ABSSSI, acute bacterial skin and skin structure infections; AwaRe, Access Watch Reserve; CAP, community-acquired pneumonia; CC, new chemical class; cIAI, complicated interabdominal infection; CRAB, carbapenem-resistant Acinetobacter baumannii; CRE, carbapenem-resistant Enterobacterales; CRPA, carbapenem-resistant P. aeruginosa; CDSCO, Central Drugs Standard Control Organization of the Government of India; cSSTI, complicated skin and soft tissue infections; cUTI, complicated urinary tract infection; EMA, European Medicines Agency; EML, essential medicines list; FDA, Food and Drug Administration (USA); HAP, hospital-acquired pneumonia; i.v., intravenous; KPC, K. pneumoniae carbapenemase; MBL, metallo-β-lactamase; OPP, other priority pathogens; MoA, new mode of action; NCR, no cross-resistance to other antibiotic classes; NMPA, China National Medical Products Administration; PDMA, Pharmaceuticals and Medical Devices Agency (Japan); T, new target; VAP, ventilator-acquired pneumonia; XDR, extensively drug-resistant.
Pathogen activity: ●, active; ?, possibly active; ○, not or insufficiently active; NA, activity not assessed, as the antibiotic is focused and developed for only either Gram-positive cocci or Gram-negative rods. Agents not active against critical-priority pathogens were assessed for activity against other priority pathogens (OPP), which includes the high and medium WHO priority pathogens.
Innovation assessment: ✓, criterion fulfilled; ?, inconclusive data; —, criterion not fulfilled.
Active against KPC- but not MBL-producing Enterobacteriaceae.
Cross-resistance can be obtained when the levels of the porin OmpK36 are varied.
First systemic formulation of this class, which was previously used in animals and topically in humans.
The approvals were obtained by the TB Alliance and then transferred to Viatris.
Approved for the treatment of XDR-TB or treatment-intolerant/nonresponsive MDR-TB, in combination with bedaquiline and linezolid.