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

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
Mechanism of action Unknown
Route of administration Intravenous
Therapeutical formulation Intravenous drip
Budgetting framework Intermural (MSZ)
Additional remarks Werkingsmechanisme: Anti-CTGF (connective tissue growth factor) human monoclonal antibody.

Registration

Registration route Centralised (EMA)
Type of trajectory Unknown
Particularity Unknown
ATMP No
Submission date 2023
Expected Registration 2024
Orphan drug No
Registration phase Clinical trials

Therapeutic value

Therapeutic value No estimate possible yet

This assessment does not indicate any potential inclusion in the package.

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

Potential total cost per year

Off label use

Off label use Unknown

Indication extension

Indication extensions Yes
Indication extensions Phase III: Ambulatory and non-ambulatory Duchenne muscular dystrophy, Pancreatic cancer
References Adis Insight

Other information