Damoctocog alfa pegol

Extended indication	Extension of indication to include treatment and prophylaxis of bleeding in previously treated patients ≥7 years of age with haemophilia A
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 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	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)

There is currently nothing known about the expected patient volume.

There is currently nothing known about the expected cost.

There is currently nothing known about the possible total cost.

There is currently nothing known about off label use.

Indication extension	No

There is currently no futher information available.