Extended indication Extension of indication to include treatment of asthma.
Registration phase Registration application pending

Product

Active substance Beclometason / formoterol / glycopyrroniumbromide
Domain Lung diseases
Reason of inclusion Indication extension IND
Main indication Asthma
Extended indication Extension of indication to include treatment of asthma.
Proprietary name Trimbow
Manufacturer Chiesi
Portfolio holder Chiesi
Route of administration Inhalation
Therapeutical formulation Inhalation powder
Budgetting framework Extramural (GVS)

Registration

Registration route Centralised (EMA)
Type of trajectory Normal trajectory
ATMP No
Submission date December 2025
Expected Registration July 2026
Orphan drug No
Registration phase Registration application pending

Therapeutic value

Frequency of administration 2 times a day
Dosage per administration 88 + 5 + 9 micrograms (2 inhalations)
References NCT02676076 (TRIMARAN)

Expected patient volume per year

Patient volume

Market share is generally not included unless otherwise stated.

Expected cost per patient per year

Cost 600.00 - 700.00

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 88 + 5 + 9 microgram metered dose inhaler (360 dose package size) €159.90. Als de patiënt in een jaar twee inhalers gebruikt zullen de kosten ongeveer €650 per patiënt zijn.

Potential total cost per year

Off label use

Indication extension

Other information