Extended indication Hyftor is indicated for the treatment of facial angiofibroma associated with tuberous sclerosis comp
Therapeutic value No estimate possible yet
Registration phase Registered

Product

Active substance Sirolimus
Domain Chronic immune diseases
Reason of inclusion New medicine (specialité)
Main indication Skin diseases
Extended indication Hyftor is indicated for the treatment of facial angiofibroma associated with tuberous sclerosis complex in adults and paediatric patients aged 6 years and older.
Proprietary name Hyftor
Manufacturer Plusultra
Portfolio holder Plusultra
Route of administration Cutaneous
Therapeutical formulation Gel
Budgetting framework Extramural (GVS)
Additional remarks mTOR remmer

Registration

Registration route Centralised (EMA)
Type of trajectory Normal trajectory
Particularity New therapeutical formulation
ATMP No
Submission date December 2021
Expected Registration May 2023
Orphan drug Yes
Registration phase Registered
Additional remarks Positieve CHMP-opinie in februari 2023.

Therapeutic value

Therapeutic value No estimate possible yet
Substantiation Dit product heeft dezelfde werkzame stof als Rapamune, maar een andere toedieningsvorm.

Expected patient volume per year

There is currently nothing known about the expected patient volume.

Expected cost per patient per year

Cost > 1,700.00
References Drugs.com
Additional remarks Sirolimus is in Nederland op dit moment nog enkel beschikbaar in tablet- en drankvorm. De kosten voor de topicale crème 1,5% bedragen rond de $1.852 voor een hoeveelheid van 60 gram in de Verenigde Staten (~€1.700). De kosten in Nederland zijn nog niet bekend.

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.