Sotatercept

Extended indication	Treatment of Pulmonary Arterial Hypertension
Therapeutic value	No estimate possible yet
Registration phase	Registration application pending

Product

Active substance	Sotatercept
Domain	Lung diseases
Reason of inclusion	New medicine (specialité)
Main indication	Lung diseases other
Extended indication	Treatment of Pulmonary Arterial Hypertension
Manufacturer	MSD
Portfolio holder	MSD
Route of administration	Subcutaneous
Therapeutical formulation	Injection
Budgetting framework	Extramural (GVS)

Registration route	Centralised (EMA)
Particularity	New medicine with Priority Medicines (PRIME)
ATMP	No
Submission date	October 2023
Expected Registration	November 2024
Orphan drug	Yes
Registration phase	Registration application pending
Additional remarks	In oktober 2022 heeft de fabrikant bekend gemaakt dat de primaire eindpunten van de STELLAR studie zijn gehaald.

Therapeutic value	No estimate possible yet
Substantiation	In de fase 2 studie werden er resultaten gevonden op de 60 minuten looptest. De resultaten uit de fase 3 studie worden nog afgewacht.
Frequency of administration	1 times every 3 weeks
Dosage per administration	0,7 mg/kg
References	NCT04576988 (STELLAR)
Additional remarks	Sotatercept at a starting dose of 0.3 mg/kg with a target dose of 0.7 mg/kg administered subcutaneously (SC) every 21 days plus background PAH therapy.

Patient volume	255 - 884 Market share is generally not included unless otherwise stated.
References	ntvg.nl
Additional remarks	De prevalentie van PAH in Nederland is ongeveer 15 tot 52 per 1 miljoen inwoners.

Patient volume

255 - 884

Market share is generally not included unless otherwise stated.

References

ntvg.nl

Additional remarks

De prevalentie van PAH in Nederland is ongeveer 15 tot 52 per 1 miljoen inwoners.

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
References	fabrikant

There is currently no futher information available.