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Setmelanotide

Imcivree

Extended indication Extension of indication to include the population of children aged 2 years and above for the treatme
Therapeutic value No estimate possible yet
Registration phase Registration application pending

Product

Active substance Setmelanotide
Domain Metabolism and Endocrinology
Reason of inclusion Indication extension
Main indication Other metabolism and Endocrinology
Extended indication Extension of indication to include the population of children aged 2 years and above for the treatment of pro-opiomelanocortin (POMC), proprotein convertase subtilisin/kexin Type 1 (PCSK1) deficiency or biallelic leptin receptor (LEPR) deficiency and Bardet-Biedl Syndrome (BBS) for IMCIVREE.
Proprietary name Imcivree
Manufacturer Rhythm
Route of administration Subcutaneous
Therapeutical formulation Injection
Budgetting framework Extramural (GVS)

Registration

Registration route Centralised (EMA)
Type of trajectory Normal trajectory
ATMP No
Submission date December 2023
Expected Registration October 2024
Orphan drug Yes
Registration phase Registration application pending

Therapeutic value

Therapeutic value No estimate possible yet
References NCT04966741

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.