Ferumoxytol

Active substance Ferumoxytol
Domain Cardiovascular diseases
Reason of inclusion in Horizonscan Geneesmiddelen New medicine (specialité)
Main indication Other non-oncological hematological medications
Extended indication Iron-deficiency anemia

Product

Proprietary name Feraheme
Manufacturer AMAG
Mechanism of action Other
Route of administration Intravenous
Therapeutical formulation Intravenous drip
Budgetting framework Intermural (MSZ)
Additional comments IJzeroxide nanopartikel dat gericht is tegen phagocyterende cellen.

Registration

Registration route Centralised (EMA)
Submission date 2020
Expected Registration 2021
Orphan drug No
Registration phase Clinical trials
Additional comments FIRM trial: reduction in hypophosphatemia. Ferumoxytol eerder op de markt gebracht door Takeda onder de merknaam Rienso en op hun verzoek weer van de markt gehaald.

Therapeutic value

Current treatment options Ferrioxidesaccharaat
Therapeutic value No judgement
Duration of treatment Average 2 week / weeks
Frequency of administration 1 times a week
Dosage per administration 510 mg
References J Blood Med. 2017; 8: 155–163. Farmacotherapeutisch kompas.

Expected patient volume per year

Patient volume

< 1,149

Market share is generally not included unless otherwise stated.

References GIP databank
Additional comments Aantal patiënten dat parenterale ijzerpreparaten heeft gekregen in 2016 betreft 1.149.

Expected cost per patient per year

Cost 2,500
References Dahl et al. Clinicoecon Outcomes Res. 2017; 9: 557–567.
Additional comments De kosten voor een kuur Feraheme in de Verenigde Staten bedragen $2.489.

Potential total cost per year

Total cost

2,872,500

This amount gives an indication of the total cost. It is the result of the average expected patient volume times the average cost per patient. both per year.

Off label use

There is currently nothing known about off label use.

Indication extension

Indication extension Yes
Indication extensions Fase 3 studie voor "Coronary Artery Disease"
References clinicaltrials.gov

Other information

There is currently no futher information available.