Lefamulin

Lefamulin (tradename Xenleta) is an antibiotic used it to treat adults with community-acquired bacterial pneumonia.[1][2] It is taken by mouth or by injection into a vein.[1][2][3]

Lefamulin
Clinical data
Trade namesXenleta
Other namesBC-3781
AHFS/Drugs.comMonograph
License data
Routes of
administration		Intravenous, by mouth
ATC code
Legal status
Legal status
Identifiers
CAS Number
PubChem CID
DrugBank
ChemSpider
UNII
KEGG
ChEMBL
Chemical and physical data
FormulaC28H45NO5S
Molar mass507.73 g·mol−1
3D model (JSmol)

Relatively common side effects include diarrhea, nausea, pain at the site of injection, and liver inflammation.[1][4] It is a pleuromutilin antibiotic.

Lefamulin was approved for medical use in the United States in 2019.[1] The wholesale cost in the United States per day is $US205 for the injectable formulation and US$275 for the tablets.[5]

Medical uses

Lefamulin is used to treat adults with community-acquired bacterial pneumonia.[1]>[2] It was also investigated for treatment of acute bacterial skin and skin-structure infections (ABSSSI).[6]

Spectrum of activity

Lefamulin has in vitro activity against Streptococcus viridans, Moraxella catarrhalis, Enterococcus faecium, methicillin-resistant Staphylococcus aureus (MRSA), among other bacteria.[7][8]

History

It was developed by Nabriva Therapeutics and approved in the United States in 2019.[1] It was granted fast track status by the US Food and Drug Administration (FDA) in 2014. Although pleuromutilin antibiotics were first developed in the 1950s, lefamulin is the first to be used for systemic treatment of bacterial infections in humans.[9]

References
  1. "FDA approves new antibiotic to treat community-acquired bacterial pneumonia". U.S. Food and Drug Administration (FDA) (Press release). 19 August 2019. Archived from the original on 20 November 2019. Retrieved 19 November 2019. This article incorporates text from this source, which is in the public domain.
  2. "Drug Trials Snapshots: Xenleta". U.S.Food and Drug Administration (FDA). 4 September 2019. Archived from the original on 20 November 2019. Retrieved 19 November 2019.
  3. File TM, Goldberg L, Das A, Sweeney C, Saviski J, Gelone SP, Seltzer E, Paukner S, Wicha WW, Talbot GH, Gasink LB (February 2019). "Efficacy and Safety of IV-to-Oral Lefamulin, a Pleuromutilin Antibiotic, for Treatment of Community-Acquired Bacterial Pneumonia: The Phase 3 LEAP 1 Trial". Clin. Infect. Dis. doi:10.1093/cid/ciz090. PMID 30722059.
  4. Alexander E, Goldberg L, Das AF, Moran GJ, Sandrock C, Gasink LB, Spera P, Sweeney C, Paukner S, Wicha WW, Gelone SP, Schranz J (September 2019). "Oral Lefamulin vs Moxifloxacin for Early Clinical Response Among Adults With Community-Acquired Bacterial Pneumonia: The LEAP 2 Randomized Clinical Trial". JAMA. doi:10.1001/jama.2019.15468. PMID 31560372.
  5. Malani, Preeti N. (27 September 2019). "Lefamulin—A New Antibiotic for Community-Acquired Pneumonia". JAMA. doi:10.1001/jama.2019.16215. ISSN 0098-7484.
  6. Zeitlinger, M; Schwameis, R; Burian, A; Burian, B; Matzneller, P; Müller, M; Wicha, W. W.; Strickmann, D. B.; Prince, W (2016). "Simultaneous assessment of the pharmacokinetics of a pleuromutilin, lefamulin, in plasma, soft tissues and pulmonary epithelial lining fluid". Journal of Antimicrobial Chemotherapy. 71 (4): 1022–6. doi:10.1093/jac/dkv442. PMID 26747098.
  7. H. Spreitzer (23 May 2016). "Neue Wirkstoffe - Lefamulin". Österreichische Apothekerzeitung (in German) (11/2016).
  8. Mendes, R. E.; Farrell, D. J.; Flamm, R. K.; Talbot, G. H.; Ivezic-Schoenfeld, Z; Paukner, S; Sader, H. S. (2016). "In vitro activity of lefamulin tested against Streptococcus pneumoniae with defined serotypes, including multidrug-resistant isolates causing lower respiratory tract infections in the United States". Antimicrobial Agents and Chemotherapy. 60: AAC.00627–16. doi:10.1128/AAC.00627-16. PMC 4914675. PMID 27161634.
  9. Veve, MP; Wagner, JL (September 2018). "Lefamulin: Review of a Promising Novel Pleuromutilin Antibiotic". Pharmacotherapy. 38 (9): 935–946. doi:10.1002/phar.2166. PMID 30019769.
  • "Lefamulin". Drug Information Portal. U.S. National Library of Medicine.
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