Extended indication

Idiopathic Pulmonary Fibrosis (IPF)

Therapeutic value

No estimate possible yet

Registration phase

Clinical trials

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

Clinical trials

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.