Extended indication Extension of indication to include treatment of FGF23-related hypophosphataemia in tumour-induced os
Therapeutic value No estimate possible yet
Registration phase Registration application pending

Product

Active substance Burosumab
Domain Metabolism and Endocrinology
Reason of inclusion Indication extension
Main indication Other metabolism and Endocrinology
Extended indication Extension of indication to include treatment of FGF23-related hypophosphataemia in tumour-induced osteomalacia (TIO) associated with phosphaturic mesenchymal tumours that cannot be curatively resected or localised in patients aged 1 year and over.
Proprietary name Crysvita
Manufacturer Kyowa
Route of administration Subcutaneous
Therapeutical formulation Injection
Budgetting framework Intermural (MSZ)
Additional comments Burosumab is een humane monoclonale anti-FGF23 antistof. Verwachte meerwaarde met name bij kinderen, ten opzichte van fosfaatsuppletie en calcitriol. Studies worden nu afgerond. Er lijkt sprake te zijn van een significante toename fysieke functies en vermindering van stijfheid.

Registration

Registration route Centralised (EMA)
ATMP No
Submission date January 2021
Expected Registration November 2021
Orphan drug Yes
Registration phase Registration application pending

Therapeutic value

Therapeutic value No estimate possible yet

Expected patient volume per year

There is currently nothing known about the expected patient volume.

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.