Lefamulin Active substance LefamulinDomain Infectious diseasesReason of inclusion in Horizonscan Geneesmiddelen New medicine (specialité)Main indication Bacterial infectionsExtended indication Pneumonia, community-acquired; moderate to severe, including atypical pneumonia 1. Product Manufacturer NabrivaMechanism of action AntibioticRoute of administration OralBudgetting framework Extramural (GVS)Additional comments pleuromutilin antibiotic, interferes with bacterial protein synthesis via a specific interaction with the 23S rRNA of the 50S bacterial ribosome subunit 2. Registration Registration route Centralised (EMA)Submission date 2019Expected Registration 2020Orphan drug NoRegistration phase Clinical trials 3. Therapeutic value Current treatment options moxifloxacineTherapeutic value Potential equal valueSubstantiation Lefamulin in klinische CAP trials is non-inferieur tov moxifloxacine. Echter, moxifloxacine is niet eerste keus voor CAP in Nederland.Duration of treatment Not foundFrequency of administration 2 times a dayDosage per administration 150 mgReferences LEAP1/2. Veve M. Rev Therapeutics 2018.Additional comments Leap2 laat behandelduur van 5 dagen zien 4. Expected patient volume per year Additional comments Beperkt aantal patiënten in Nederland. 5. Expected cost per patient per year There is currently nothing known about the expected cost. 6. Potential total cost per year There is currently nothing known about the possible total cost. 7. Off label use There is currently nothing known about off label use. 8. Indication extension Indication extension No 9. Other information There is currently no futher information available.