Extended indication Relapsing multiple sclerosis
Therapeutic value Possible equal value
Registration phase Clinical trials

Product

Active substance Ublituximab
Domain Neurological disorders
Reason of inclusion New medicine (specialité)
Main indication Multiple sclerosis
Extended indication Relapsing multiple sclerosis
Manufacturer TG Therapeutics
Mechanism of action Immunostimulation
Route of administration Intravenous
Therapeutical formulation Intravenous drip
Budgetting framework Intermural (MSZ)

Registration

Registration route Centralised (EMA)
Type of trajectory Normal trajectory
ATMP No
Submission date 2022
Expected Registration 2023
Orphan drug No
Registration phase Clinical trials
Additional comments Indiening bij de FDA verwacht in september 2021.

Therapeutic value

Current treatment options Alemtuzumab, cladribine, fingolimod, glatiramer,interferon bèta-1a, interferon bèta-1b, natalizumab, ocrelizumab, peginterferon bèta-1a, teriflunomide
Therapeutic value Possible equal value
Substantiation In de fase 3 trial werd superioriteit gezien ten opzichte van teriflunomide op basis van de multiple sclerosis functional composite (MSFC) score. Er wordt concurrentie met ocrelizumab (en rituximab) en ofatumumab als concurrerende anti-B cel therapie verwacht.
References NCT03277261; NCT03277248

Expected patient volume per year

Patient volume

< 200

Market share is generally not included unless otherwise stated.

References GIP databank, hersenstichting, Nationaal MS fonds.
Additional comments Hersenstichting: In Nederland komt Multiple Sclerosis voor bij ongeveer 1 op de 1.000 inwoners. Nederland telt dus ongeveer 17.000 mensen met Multiple Sclerosis. RMS komt bij ongeveer 40% van alle mensen met Multiple Sclerosis voor (6.800 personen). Door de concurrentie aan middelen zal het verwachte marktaandeel op maximaal een paar honderd patiënten komen te liggen.

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 Diffuse large B cell lymphoma; Follicular lymphoma; Mantle-cell lymphoma; Marginal zone B-cell lymphoma
References AdisInsight

Other information

There is currently no futher information available.