Lefamulin

Active substance
Lefamulin
Domain
Infectious diseases
Reason of inclusion in Horizonscan Geneesmiddelen
New medicine (specialité)
Main indication
Bacterial infections
Extended indication
Pneumonia, community-acquired; moderate to severe, including atypical pneumonia

1. Product

Manufacturer
Nabriva
Mechanism of action
Antibiotic
Route of administration
Oral
Budgetting 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
2019
Expected Registration
2020
Orphan drug
No
Registration phase
Clinical trials

3. Therapeutic value

Current treatment options
moxifloxacine
Therapeutic value
Potential 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 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.