Extended indication Treatment of Pulmonary Arterial Hypertension
Therapeutic value No estimate possible yet
Registration phase Clinical trials

Product

Active substance Sotatercept
Domain Cardiovascular diseases
Reason of inclusion New medicine (specialité)
Main indication Other medication for cardiovascular diseases
Extended indication Treatment of Pulmonary Arterial Hypertension
Manufacturer Acceleron
Route of administration Subcutaneous
Therapeutical formulation Injection
Budgetting framework Extramural (GVS)

Registration

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

Therapeutic value

Therapeutic value No estimate possible yet
Substantiation In de fase 2 studie geweest 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 comments 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.

Expected patient volume per year

Patient volume

255 - 884

Market share is generally not included unless otherwise stated.

References ntvg.nl
Additional comments De prevalentie van PAH in Nederland is ongeveer 15-52 per 1 miljoen inwoners.

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

There is currently nothing known about indication extensions.

Other information

There is currently no futher information available.