Ruxolitinib

Extended indication	Extension of indication for the treatment of adults and paediatric patients aged 28 days and older with acute graft versus host disease who have inadequate response to corticosteroids or other systemic therapies and for the treatment of adults and paediatric patients aged 6 months and older with chronic graft versus host disease who have inadequate response to corticosteroids or other systemic therapies.
Therapeutic value	No estimate possible yet
Registration phase	Positive CHMP opinion

Product

Active substance	Ruxolitinib
Domain	Hematology
Reason of inclusion	New medicine (specialité)
Main indication	Graft versus Host
Extended indication	Extension of indication for the treatment of adults and paediatric patients aged 28 days and older with acute graft versus host disease who have inadequate response to corticosteroids or other systemic therapies and for the treatment of adults and paediatric patients aged 6 months and older with chronic graft versus host disease who have inadequate response to corticosteroids or other systemic therapies.
Proprietary name	Jakavi
Manufacturer	Novartis
Route of administration	Oral
Therapeutical formulation	Solution
Budgetting framework	Intermural (MSZ)

Registration route	Centralised (EMA)
Type of trajectory	Normal trajectory
ATMP	No
Submission date	January 2024
Expected Registration	January 2025
Orphan drug	No
Registration phase	Positive CHMP opinion
Additional remarks	Positieve CHMP-opinie november 2024

Therapeutic value	No estimate possible yet

There is currently nothing known about the expected patient volume.

There is currently nothing known about the expected cost.

There is currently nothing known about the possible total cost.

There is currently nothing known about off label use.

There is currently nothing known about indication extensions.

There is currently no futher information available.