Expand all sections

Eculizumab

Soliris

Extended indication Extension of indication to include treatment of paediatric patients aged 6 to less than 18 years wit
Therapeutic value No estimate possible yet
Registration phase Registration application pending

Product

Active substance Eculizumab
Domain Neurological disorders
Reason of inclusion Indication extension
Main indication Muscular diseases other
Extended indication Extension of indication to include treatment of paediatric patients aged 6 to less than 18 years with acetylcholine receptor-antibody (AChR-Ab) positive (+) refractory gMG.
Proprietary name Soliris
Manufacturer Alexion
Route of administration Intravenous
Therapeutical formulation Intravenous drip
Budgetting framework Intermural (MSZ)

Registration

Registration route Centralised (EMA)
Type of trajectory Normal trajectory
Submission date February 2023
Expected Registration November 2023
Orphan drug Yes
Registration phase Registration application pending

Therapeutic value

Therapeutic value No estimate possible yet
Duration of treatment continuous
Frequency of administration 1 times every 2 weeks
Dosage per administration 300 - 1200mg
References NCT03759366
Additional remarks Eculizumab will be administered at doses of 300, 600, 900, or 1200 milligrams (mg), based on the participant's current body weight. In the Primary Evaluation Treatment Period (26 weeks), eculizumab will be administered weekly during the initial induction phase and every 2 weeks during the maintenance phase.

Expected patient volume per year

References https://www.spierziekten.nl/fileadmin/user_upload/VSN/documenten/Huisartsenbrochures/M010-MG-habrochmetbrieven.pdf
Additional remarks De prevalentie is 1 patiënt per 10.000 inwoners.

Expected cost per patient per year

Additional remarks Voor alle indicaties van eculizumab geldt een financieel arrangement lopend tot en met 31 december 2025

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.