Tanimilast Medicine 03 June 2025 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. Therapeutic value No estimate possible yet Total cost Registration phase Clinical trials Product Active substance Tanimilast Domain Lung diseases Reason of inclusion New medicine (specialité) Main indication Unknown 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. Current proprietary name Already available biosimilars / generics Proprietary name Manufacturer Chiesi Portfolio holder Mechanism of action Unknown Route of administration Inhalation Therapeutical formulation Unknown Budgetting framework Extramural (GVS) Centre of expertise Additional remarks Powder for pulmonary inhalation Registration Registration route Centralised (EMA) Type of trajectory Normal trajectory Particularity Unknown ATMP No Submission date September 2025 Expected Registration October 2026 Orphan drug No Registration phase Clinical trials Reimbursement Medicine sluice Additional remarks Therapeutic value Current treatment options Therapeutic value No estimate possible yet This assessment does not indicate any potential inclusion in the package. Substantiation De resultaten van de fase 3 studie (NCT04636801) worden in juni 2025 verwacht wordt in juni 2025 verwacht. Duration of treatment Frequency of administration Dosage per administration References Additional remarks Expected patient volume per year Patient volume Market share is generally not included unless otherwise stated. Maximum patient volume for sluice 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 Cost References Additional remarks Potential total cost per year Total cost Total cost for sluice Additional remarks Off label use Off label use Unknown Indications off label use References Additional remarks Indication extension Indication extensions Unknown Indication extensions References Additional remarks Other information Additional remarks