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Sotatercept

Winrevair

Extended indication Treatment of Pulmonary Arterial Hypertension
Therapeutic value Possible added value
Registration phase Registered

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
Proprietary name Winrevair
Manufacturer MSD
Portfolio holder MSD
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 October 2023
Expected Registration August 2024
Orphan drug Yes
Registration phase Registered
Additional remarks Positieve CHMP-opinie juni 2024

Therapeutic value

Therapeutic value Possible added value
Substantiation Sotatercept zal volgens experts een mogelijke meerwaarde kunnen gaan hebben in de behandeling van PAH. Bij studie patiënten of patiënten in het Early Access programma worden goede resultaten gezien. Daarnaast zijn de resultaten uit de fase 3 studie indrukwekkend te noemen, zeker in vergelijking met de resultaten van veel andere medicamenten binnen deze indicatie.
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.

Expected patient volume per year

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.

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
References fabrikant

Other information

There is currently no futher information available.