Afamelanotide

Extended indication	Extension of indication for the prevention of phototoxicity in adolescent patients (12 to under 18 years of age) with erythropoietic protoporphyria (EPP).
Therapeutic value	No estimate possible yet
Registration phase	Registration application pending

Product

Active substance	Afamelanotide
Domain	Metabolism and Endocrinology
Reason of inclusion	Indication extension
Main indication	Metabolic diseases
Extended indication	Extension of indication for the prevention of phototoxicity in adolescent patients (12 to under 18 years of age) with erythropoietic protoporphyria (EPP).
Proprietary name	Scenesse
Manufacturer	Clinuvel
Route of administration	Subcutaneous
Therapeutical formulation	Implant
Budgetting framework	Intermural (MSZ)

Registration route	Centralised (EMA)
Type of trajectory	Normal trajectory
ATMP	No
Submission date	February 2023
Expected Registration	December 2023
Orphan drug	Yes
Registration phase	Registration application pending

Therapeutic value	No estimate possible yet

There is currently nothing known about the expected patient volume.

Cost	13,986.00
References	medicijnkosten.nl
Additional remarks	Gemiddelde prijs per 1 injectieflacon Scenesse, implantaat 16 mg € 15.370,04 incl. btw.

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.