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Rusfertide

Extended indication Polycythemia Vera
Therapeutic value No estimate possible yet
Registration phase Clinical trials

Product

Active substance Rusfertide
Domain Cardiovascular diseases
Reason of inclusion New medicine (specialité)
Main indication Other non-oncological hematological medications
Extended indication Polycythemia Vera
Manufacturer Protagonist
Route of administration Subcutaneous
Therapeutical formulation Injection
Budgetting framework Extramural (GVS)
Additional remarks Fabrikant: Protagonist Therapeutics. Hepcidin replacements; Iron modulators

Registration

Registration route Centralised (EMA)
Type of trajectory Normal trajectory
ATMP No
Submission date November 2025
Expected Registration December 2026
Orphan drug No
Registration phase Clinical trials
Additional remarks Indieningsdatum en verwachte registratie op basis van IHSI-inschatting.

Therapeutic value

Current treatment options Celgroeiremmende middelen: hydroxycarbamide (Hydrea®), peginterferon-alfa-2a (Pegasys®) of Ruxolitinib (Jakavi®) (2)
Therapeutic value No estimate possible yet
References NCT05210790 (VERIFY) (1); Achtergronden bij de polycythemia vera (PV)-richtlijn 2019, Nederlands Tijdschrift voor Hematologie (2019,16:123-130) (2)

Expected patient volume per year

References Polycythemia vera. MPN stichting. 2024 (1).
Additional remarks Polycythemia vera is een zeldzame bloedziekte en komt naar schatting voor bij ongeveer 2,3 per 100.000 mensen (1).

Expected cost per patient per year

There is currently nothing known about the expected cost.

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

There is currently nothing known about indication extensions.

Other information

There is currently no futher information available.