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Efanesoctocog alfa

Extended indication Treatment and prophylaxis of bleeding in patients with haemophilia A
Therapeutic value No estimate possible yet
Registration phase Registration application pending

Product

Active substance Efanesoctocog alfa
Domain Cardiovascular diseases
Reason of inclusion New medicine (specialité)
Main indication Other non-oncological hematological medications
Extended indication Treatment and prophylaxis of bleeding in patients with haemophilia A
Manufacturer Sobi
Portfolio holder Sobi
Mechanism of action Coagulant
Route of administration Intravenous
Therapeutical formulation Intravenous drip
Budgetting framework Intermural (MSZ)
Additional remarks Factor VIII replacement.

Registration

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

Therapeutic value

Therapeutic value No estimate possible yet
Frequency of administration 1 times a week
Dosage per administration 50 UI/kg
References NCT05817812 (Freedom)

Expected patient volume per year

There is currently nothing known about the expected patient volume.

Expected cost per patient per year

Cost < 260,000.00
References https://www.biopharmadive.com/news/sanofi-bioverativ-fda-approve-drug-rare-anemia/618416/
Additional remarks In de Verenigde Staten is de lijstprijs bekend. Dit is 280.000 dollar per patiënt per jaar voor een gemiddelde patiënt van 75 kg (1800 dollar per dosis). Omgerekend naar euro is dat €260.000 . De prijs in Nederland is nog niet bekend. Waarschijnlijk zal deze prijs lager zijn in Nederland.

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.