Extended indication Essential thrombocythaemia.
Therapeutic value No estimate possible yet
Registration phase Clinical trials

Product

Active substance Bomedemstat
Domain Hematology
Reason of inclusion New medicine (specialité)
Main indication Myeloproliferative disorders
Extended indication Essential thrombocythaemia.
Manufacturer MSD
Route of administration Oral
Therapeutical formulation Capsule
Budgetting framework Intermural (MSZ)
Additional remarks Lysine specific demethylase 1 inhibitor.

Registration

Registration route Centralised (EMA)
ATMP No
Submission date 2027
Expected Registration 2028
Orphan drug Yes
Registration phase Clinical trials
Additional remarks Fabrikant heeft aangegeven dat registratie verwacht wordt in 2028 (aangegeven in februari 2024).

Therapeutic value

Therapeutic value No estimate possible yet

This assessment does not indicate any potential inclusion in the package.

Frequency of administration 1 times a day

Expected patient volume per year

Patient volume < 166

Market share is generally not included unless otherwise stated.

References NKR 2018 (1);
Additional remarks In totaal waren er 166 diagnoses in 2018 (1).

Expected cost per patient per year

Additional remarks Er is nog niets bekend over de mogelijke prijs.

Potential total cost per year

Off label use

Indication extension

Other information