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Somatrogon

Ngenla

Extended indication

Somatrogon monotherapy for treatment of growth hormone deficiency in adults
Therapeutic value

No estimate possible yet
Registration phase

Registration application pending

Product

Active substance

Somatrogon
Domain

Metabolism and Endocrinology
Reason of inclusion

Indication extension
Main indication

Metabolic diseases
Extended indication

Somatrogon monotherapy for treatment of growth hormone deficiency in adults
Proprietary name

Ngenla
Manufacturer

Pfizer
Portfolio holder

Pfizer
Mechanism of action

Hormonal therapy
Route of administration

Subcutaneous
Therapeutical formulation

Injection
Budgetting framework

Intermural (MSZ)
Additional remarks 
Dit geneesmiddel is in 2022 geregistreerd en vergoed voor kinderen en adolescenten vanaf 3 jaar. Dit betreft de indicatieuitbreiding naar volwassenen.

Registration

Registration route

Centralised (EMA)
Type of trajectory

Normal trajectory
ATMP

No
Submission date

June 2024
Expected Registration

May 2025
Orphan drug

Yes
Registration phase

Registration application pending
Additional remarks 
Verwachte registratie aan de hand van inschatting van de fabrikant.

Therapeutic value

Current treatment options

Dagelijkse somatropine injecties, TransCon Growth Hormone, somapacitan
Therapeutic value

No estimate possible yet
Frequency of administration

1 times a week
References 
NCT01909479
Additional remarks 
Behandelduur is persoonsafhankelijk.

Expected patient volume per year

There is currently nothing known about the expected patient volume.

Expected cost per patient per year

Cost

< 26,112.98
References 
Medicijnkosten.nl
Additional remarks 
Kosten Ngenla 24 mg: €219,19 (incl. BTW), Ngenla 60 mg: €545,48 (incl. BTW) (1). Een wekelijkse behandeling met 60 mg kost €26.112,98 (excl. BTW) p.p.p.j. (€545,48/1,09∗52,18).

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.