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Tanimilast

Extended indication Tanimilast in combination with maintenance triple therapy for adjunctive treatment of chronic obstru
Therapeutic value No estimate possible yet
Registration phase Clinical trials

Product

Active substance Tanimilast
Domain Lung diseases
Reason of inclusion New medicine (specialité)
Extended indication Tanimilast in combination with maintenance triple therapy for adjunctive treatment of chronic obstructive pulmonary disease (COPD) in adults and elderly with chronic bronchitis.
Manufacturer Chiesi
Route of administration Inhalation
Budgetting framework Extramural (GVS)
Additional remarks Powder for pulmonary inhalation

Registration

Registration route Centralised (EMA)
Type of trajectory Normal trajectory
ATMP No
Submission date September 2025
Expected Registration October 2026
Orphan drug No
Registration phase Clinical trials

Therapeutic value

Therapeutic value No estimate possible yet
Substantiation De resultaten van de fase 3 studie (NCT04636801) worden in juni 2025 verwacht wordt in juni 2025 verwacht.

Expected patient volume per year

References CBS; volksgezondheidenzorg.info; LAN standaard COPD, Mullerova H, et al. American journal of respiratory and critical care medicine. 2017;195:A4986., Brusselle G, et al. Int J Chron Obstruct Pulmon Dis. 2015;10:2207-17.
Additional remarks Van de 17 miljoen inwoners in Nederland heeft 3,4% COPD (chronische bronchitis en/of emfyseem,537.500 patiënten in 2023, 18% hiervan heeft ernstige COPD (ongeveer 96.750 patiënten) en 54% hiervan heeft matig tot ernstige COPD (ongeveer 290.250 patiënten). Dit geneesmiddel zal waarschijnlijk ingezet gaan worden voor een subgroep van COPD met een type 2 endotype die ook al ICS gebruikt.

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

There is currently nothing known about indication extensions.

Other information

There is currently no futher information available.