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Delafloxacin

Quofenix

Extended indication Extension of indication to include treatment of Community Acquired Pneumonia (CAP) for Quofenix 450m
Therapeutic value Possible equal value
Registration phase Positive CHMP opinion

Product

Active substance Delafloxacin
Domain Infectious diseases
Reason of inclusion Indication extension
Main indication Bacterial infections
Extended indication Extension of indication to include treatment of Community Acquired Pneumonia (CAP) for Quofenix 450mg tablets and 300mg powder for concentrate for solution for infusion.
Proprietary name Quofenix
Manufacturer Menarini
Mechanism of action Antibiotic
Route of administration Intravenous
Therapeutical formulation Intravenous drip
Budgetting framework Intermural (MSZ)
Additional comments Ook beschikbaar als tablet. DNA gyrase inhibitor; DNA topoisomerase IV inhibitor; Protein 50S ribosomal subunit inhibitor.

Registration

Registration route Centralised (EMA)
Type of trajectory Normal trajectory
Submission date April 2020
Expected Registration June 2021
Orphan drug No
Registration phase Positive CHMP opinion
Additional comments Indiening voor deze indicatie bij de FDA verwacht in de eerste helft van 2019. Positieve CHMP-opinie in februari 2021.

Therapeutic value

Current treatment options Afhankelijk van de diagnose: amoxicilline, doxycycline, azitromycine, claritromycine, cotrimoxazol, levofloxacine, moxifloxacine.
Therapeutic value Possible equal value
Substantiation Geen meerwaarde ten opzichte van levofloxacin en moxifloxacin.
Frequency of administration 2 times a day
Dosage per administration 300 - 450 mg
References Farmcotherapeutisch Kompas; NCT02679573
Additional comments 300mg IV, Q12H for at least 6 doses with potential to switch to 450mg oral tablet, Q12H for up to 20 doses total

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.

Expected cost per patient per year

Cost < € 1,358.00
References https://www.sps.nhs.uk/medicines/delafloxacin/
Additional comments 10 tabletten van Quofenix in het Verenigd Koninkrijk is £615. Dit is omgerekend €678,88. 20 tabletten per behandeling is maximaal €1.358. De definitieve prijs in Nederland is nog niet bekend.

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 Yes

Other information

There is currently no futher information available.