Extended indication Tozorakimab monotherapy for treatment of symptomatic Chronic obstructive pulmonary disease in adults and elderly with history of COPD exacerbations.
Registration phase Clinical trials

Product

Active substance Tozorakimab
Domain Lung diseases
Reason of inclusion New medicine (specialité)
Main indication COPD
Extended indication Tozorakimab monotherapy for treatment of symptomatic Chronic obstructive pulmonary disease in adults and elderly with history of COPD exacerbations.
Manufacturer AstraZeneca
Mechanism of action Interleukin inhibitor
Route of administration Subcutaneous
Therapeutical formulation Injection
Budgetting framework Extramural (GVS)
Additional remarks IL-33 binding antibody

Registration

Registration route Centralised (EMA)
Type of trajectory Normal trajectory
ATMP No
Submission date June 2026
Expected Registration November 2027
Registration phase Clinical trials
Additional remarks Tijdslijn op basis van IHSI-inschatting.

Therapeutic value

References (NCT05158387), OBERON (NCT05166889), MIRANDA (NCT06040086), and PROSPERO (NCT05742802).

Expected patient volume per year

Patient volume

Market share is generally not included unless otherwise stated.

References CBS, https://goldcopd.org/
Additional remarks In Nederland hebben circa 600.000 volwassenen een vastgestelde diagnose COPD. 30 tot 40% van de COPD-patiënten heeft meer dan een matige of ernstige exacerbatie per jaar.

Expected cost per patient per year

Cost 13,000.00

This amount gives an indication of the total cost. It is the result of the average expected patient volume times the average cost per patient. both per year.

Additional remarks Kosten op basis van IHSI-inschatting, afgeleid van de mediane kosten van dezelfde ATC-klasse (L04AC - interleukineremmers) geneesmiddelen in Nederland.

Potential total cost per year

Off label use

Indication extension

Other information