Extended indication Advanced chronic heart failure in patients who are no longer responsive to maximal standard of care
Therapeutic value No estimate possible yet
Registration phase Clinical trials

Product

Active substance Rexlemestrocel-L
Domain Cardiovascular diseases
Reason of inclusion New medicine (specialité)
Main indication Other medication for cardiovascular diseases
Extended indication Advanced chronic heart failure in patients who are no longer responsive to maximal standard of care heart failure drugs
Manufacturer Teva
Route of administration Intracardiac
Budgetting framework Intermural (MSZ)

Registration

Registration route Centralised (EMA)
Submission date 2022
Expected Registration 2023
Orphan drug Yes
Registration phase Clinical trials
Additional comments Primary completion datum in mei 2020.

Therapeutic value

Current treatment options Harttransplantatie
Therapeutic value No estimate possible yet
Substantiation In de afgelopen jaren zijn er nog geen goede resultaten bij vergelijkbare medicamenten gevonden. Op dit lopen de onderzoeken nog. Patiënten die niet in aanmerking komen voor een harttransplantatie, maar deze wel nodig hebben zouden in aanmerking kunnen komen voor deze behandeling.
References NCT02032004 (DREAM HF-1)

Expected patient volume per year

References RIVM
Additional comments Patiënten die niet in aanmerking komen voor een harttransplantatie, maar deze wel nodig hebben zouden in aanmerking kunnen komen voor deze behandeling.

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

Indication extension Yes
Indication extensions Acute myeloid leukaemia; Hodgkin's disease; Intervertebral disc degeneration; Non-Hodgkin's lymphoma; Precursor cell lymphoblastic leukaemia-lymphoma
References Adisinsight
Additional comments Meerdere lopende fase 3 studies.

Other information

There is currently no futher information available.