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Damoctocog alfa pegol

Jivi

Extended indication Extension of indication to include treatment and prophylaxis of bleeding in previously treated patie
Therapeutic value No estimate possible yet
Registration phase Registration application pending

Product

Active substance Damoctocog alfa pegol
Domain Cardiovascular diseases
Reason of inclusion Indication extension
Main indication Hemostasis promoting medication
Extended indication Extension of indication to include treatment and prophylaxis of bleeding in previously treated patients ≥7 years of age with haemophilia A
Proprietary name Jivi
Manufacturer Bayer
Mechanism of action Coagulant
Route of administration Intravenous
Therapeutical formulation Injection
Budgetting framework Intermural (MSZ)
Centre of expertise Hemofilie Behandel Centra
Additional remarks Dit betreft de uitbreiding van de bestaande indicatie van 7 naar 12 jaar en ouder.

Registration

Registration route Centralised (EMA)
Type of trajectory Normal trajectory
ATMP No
Submission date November 2024
Expected Registration September 2025
Orphan drug No
Registration phase Registration application pending
Additional remarks Verwachte registratie op basis van een gemiddelde doorlooptijd van 10 maanden voor een indicatieuitbreiding.

Therapeutic value

Therapeutic value No estimate possible yet
Duration of treatment continuous
Frequency of administration 2 times a week
Dosage per administration 40-60 IE/kg
References NCT05147662 (Alfa-PROTECT); NCT01775618 (PROTECT VIII Kids)

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

Indication extension No

Other information

There is currently no futher information available.