Delafloxacin

Active substance
Delafloxacin
Domain
Infectious diseases
Reason of inclusion in Horizonscan Geneesmiddelen
Indication extension
Main indication
Bacterial infections
Extended indication
Community acquired pneumonia

1. Product

Proprietary name
Quofenix
Manufacturer
Menarini
Mechanism of action
Antibiotic
Route of administration
Intravenous
Therapeutical formulation
Intravenous drip
Additional comments
Ook beschikbaar als tablet. DNA gyrase inhibitor; DNA topoisomerase IV inhibitor; Protein 50S ribosomal subunit inhibitor.

2. Registration

Registration route
Centralised (EMA)
Type of trajectory
Normal trajectory
Submission date
2019
Expected Registration
2020
Orphan drug
No
Registration phase
Clinical trials
Additional comments
Indiening voor deze indicatie bij de FDA verwacht in H1 2019.

3. Therapeutic value

Current treatment options
Afhankelijk van de diagnose: amoxicilline, doxycycline, azitromycine, claritromycine, cotrimoxazol, levofloxacine, moxifloxacine.
Therapeutic value
No judgement yet
Substantiation
Geen meerwaarde tov levofloxacin en moxifloxacin.
Duration of treatment
Not found
Frequency of administration
2 times a day
Dosage per administration
300 - 450 mg
References
Farmcotherapeutisch Kompas; NCT02679573
Additional comments
300 mg IV, Q12H for at least 6 doses with potential to switch to 450 mg oral tablet, Q12H for up to 20 doses total

4. Expected patient volume per year

References
Aleva en Boersma. Ned Tijdschr Geneeskd. 2005;149:2501-7; Verheij en Boudry, Ge-Bu, Nr 7, 2006 (40), Pagina 73-79
Additional comments
De incidentie van CAP in de huisartsenpraktijk is 5-8 per 1.000 patiënten per jaar (in totaal 85.000-136.000). Ongeveer één op de tien patiënten wordt in een ziekenhuis opgenomen (8.500-13.600). Het totaal aantal patiënten dat in aanmerking zal komen voor deze behandeling is verwaarloosbaar in Nederland bij CAP.

5. Expected cost per patient per year

References
GoodRx.com
Additional comments
20 tabletten van Baxdela 450mg betreft $1,350.00.

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
Yes

9. Other information

There is currently no futher information available.