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Pamrevlumab

Extended indication Idiopathic Pulmonary Fibrosis (IPF)
Therapeutic value No estimate possible yet
Registration phase No registration expected

Product

Active substance Pamrevlumab
Domain Lung diseases
Reason of inclusion New medicine (specialité)
Main indication Lung diseases other
Extended indication Idiopathic Pulmonary Fibrosis (IPF)
Manufacturer Fibrogen
Route of administration Intravenous
Therapeutical formulation Intravenous drip
Budgetting framework Intermural (MSZ)
Additional remarks Werkingsmechanisme: Anti-CTGF (bindweefselgroeifactor) humaan monoklonaal antilichaam.

Registration

Registration route Centralised (EMA)
ATMP No
Submission date 2025
Expected Registration 2026
Orphan drug No
Registration phase No registration expected
Additional remarks Fibrogen heeft in juni 2023 aangekondigd dat de fase 3 ZEPHYRUS-1 trial niet het primaire eindpunt heeft behaald.

Therapeutic value

Therapeutic value No estimate possible yet
Dosage per administration 30 mg/kg
References NCT04419558, NCT03955146

Expected patient volume per year

Patient volume

< 2,040

Market share is generally not included unless otherwise stated.
References Jaarverslag Longfibrosepatiëntenvereniging 2017 (1)
Additional remarks Er zijn ongeveer 3.400 longfibrose patiënten in Nederland. 60% daarvan heeft IPF. Dit komt neer op 2.040 IPF patiënten.

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 Yes
Indication extensions Fase 3: Ambulante en niet-ambulante Duchenne spierdystrofie, alvleesklierkanker.
References Adis Insight

Other information

There is currently no futher information available.