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

Product

Active substance Zinpentraxin alfa
Domain Lung diseases
Reason of inclusion New medicine (specialité)
Main indication Lung diseases other
Extended indication Idiopathic Pulmonary Fibrosis (IPF)
Manufacturer Roche
Portfolio holder Roche
Route of administration Intravenous
Therapeutical formulation Intravenous drip
Budgetting framework Intermural (MSZ)
Additional remarks A recombinant form of human pentraxin-2 protein able to regulate monocytes and macrophages at areas of tissue damage to prevent and reverse fibrosis.

Registration

Registration route Centralised (EMA)
ATMP No
Submission date 2024
Expected Registration 2025
Orphan drug Yes
Registration phase No registration expected
Additional remarks De fabrikant geeft aan niet langer registratie te verwachten van dit product.

Therapeutic value

Therapeutic value No estimate possible yet
Frequency of administration 1 times every 4 weeks
Dosage per administration 10 mg/kg
References NCT04594707, NCT04552899

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 Phase II: Myelofibrosis
References SPS UK

Other information

There is currently no futher information available.