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Satralizumab

Enspryng

Extended indication

Patients with neuromyelitis optica (NMO) or neuromyelitis optica spectrum disorders (NMOSD).
Therapeutic value

No judgement
Registration phase

Clinical trials

Product

Active substance

Satralizumab
Domain

Chronic immune diseases
Reason of inclusion

New medicine (specialité)
Main indication

Eye disorders
Extended indication

Patients with neuromyelitis optica (NMO) or neuromyelitis optica spectrum disorders (NMOSD).
Proprietary name

Enspryng
Manufacturer

Roche
Mechanism of action

Receptor antagonist
Route of administration

Subcutaneous
Therapeutical formulation

Injection
Budgetting framework

Intermural (MSZ)
Centre of expertise

ErasmusMC
Additional remarks 
Humanised IgG2 monoclonal antibody against the human interleukin-6 receptor (IL-6R)

Registration

Registration route

Centralised (EMA)
Type of trajectory

Normal trajectory
Submission date

October 2019
Expected Registration

November 2020
Orphan drug

Yes
Registration phase

Clinical trials

Therapeutic value

Current treatment options

Methylprednisolon vooral aanvalsbehandeling gegeven, net als plasmaferese en eventueel IVIG. Satralizumab bedoeld ter preventie van volgende relapse. Daar wordt nu azathioprine (naast orale taper prednison) voor gegeven of rituximab of mycofenolaat mofetil.
Therapeutic value

No judgement
Substantiation

therapeutische waarde nog niet goed in te schatten
Frequency of administration

1 times every 4 weeks
Dosage per administration

120 mg
References 
Fabrikant
Additional remarks 
Eerste drie toedieningen zijn om de twee weken

Expected patient volume per year

Patient volume

< 70

Market share is generally not included unless otherwise stated.
References 
Marrie and Gryba. Int J MS Care. 2013 Fall; 15(3): 113–118; Tackley et al. Mult Scler Relat Disord. 2016 May;7:21-5
Additional remarks 
Incidentie van NMO ligt rond de 0,4 per 100.000 inwoners, dit betekent voor Nederland ongeveer 70 patiënten. Dit betreft echter wel het maximum gezien  niet alle NMO patiënten in aanmerking zullen komen voor dit geneesmiddel. Er is op dit moment al een effectieve therapie en daarnaast zijn sommige patiënten te ernstig aangedaan en anderen te gering.

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.