Ozenoxacine

Active substance
Ozenoxacine
Domain
Infectious diseases
Reason of inclusion in Horizonscan Geneesmiddelen
New medicine (specialité)
Main indication
Bacterial infections
Extended indication
Kortetermijnbehandeling van niet-bulleuze impetigo (krentenbaard) bij volwassenen, adolescenten en kinderen vanaf 2 jaar.

1. Product

Proprietary name
Ozenoxacin Ferrer
Manufacturer
Ferrer Internat
Mechanism of action
Antibiotic
Route of administration
Cutaneous
Therapeutical formulation
Cream
Budgetting framework
Extramural (GVS)
Additional comments
Non-fluorinated quinolone antibacterial agent

2. Registration

Registration route
Centralised (EMA)
Submission date
2020
Expected Registration
2021
Orphan drug
No
Registration phase
Clinical trials
Additional comments
Vervolgonderzoek gewenst door CBG naar het risico op de ontwikkeling van antibioticaresistentie per juli 2017. Goedgekeurd door de FDA en in Canada.

3. Therapeutic value

Therapeutic value
No judgement
Substantiation
Geen meerwaarde verwacht. Genoeg behandelmethoden dus weinig plek. (Gelijke waarde niet aan te geven gezien de vergelijkende behandeling in de studies placebo-vehicle is).
Duration of treatment
Average 5 day / days
Frequency of administration
2 times a day

4. Expected patient volume per year

Additional comments
Aantal patiënten heel klein.

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.