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Lefamulin

Extended indication Pneumonia, community-acquired; moderate to severe, including atypical pneumonia
Therapeutic value Possible equal value
Registration phase Clinical trials

Product

Active substance Lefamulin
Domain Infectious diseases
Reason of inclusion New medicine (specialité)
Main indication Bacterial infections
Extended indication Pneumonia, community-acquired; moderate to severe, including atypical pneumonia
Manufacturer Nabriva
Route of administration Oral
Budgetting framework Extramural (GVS)
Additional remarks pleuromutilin antibiotic, interferes with bacterial protein synthesis via a specific interaction with the 23S rRNA of the 50S bacterial ribosome subunit

Registration

Registration route Centralised (EMA)
Submission date 2019
Expected Registration 2020
Orphan drug No
Registration phase Clinical trials

Therapeutic value

Current treatment options moxifloxacine
Therapeutic value Possible equal value
Substantiation Lefamulin in klinische CAP trials is non-inferieur tov moxifloxacine. Echter, moxifloxacine is niet eerste keus voor CAP in Nederland.
Duration of treatment Not found
Frequency of administration 2 times a day
Dosage per administration 150 mg
References LEAP1/2. Veve M. Rev Therapeutics 2018.
Additional remarks Leap2 laat behandelduur van 5 dagen zien

Expected patient volume per year

Additional remarks Beperkt aantal patiënten in Nederland.

Expected cost per patient per year

There is currently nothing known about the expected cost.

Potential total cost per year

There is currently nothing known about the possible total cost.

Off label use

There is currently nothing known about off label use.

Indication extension

Indication extension No

Other information

There is currently no futher information available.