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Nerandomilast

Extended indication Nerandomilast is a medicine used to treat adults with idiopathic pulmonary fibrosis (IPF) and progre
Therapeutic value No estimate possible yet
Registration phase Clinical trials

Product

Active substance Nerandomilast
Domain Lung diseases
Reason of inclusion New medicine (specialité)
Main indication Lung diseases other
Extended indication Nerandomilast is a medicine used to treat adults with idiopathic pulmonary fibrosis (IPF) and progressive pulmonary fibrosis (PPF). A disease of unknown cause in which connective tissue forms in the lungs; systemic sclerosis-associated interstitial lung disease, is a disease in which the immune system (the body's natural defences) is overactive. Which leads to the production of connective tissue and progressive scarring in the lungs; and other chronic fibrosing interstitial lung diseases that are progressive.
Manufacturer Boehringer Ingelheim
Portfolio holder Boehringer Ingelheim
Mechanism of action Other
Route of administration Oral
Therapeutical formulation Coated tablet
Budgetting framework Extramural (GVS)
Centre of expertise Erasmus MC Rotterdam, St Antonius Ziekenhuis Nieuwegein, OLVG Amsterdam, Amsterdam UMC

Registration

Registration route Centralised (EMA)
ATMP No
Submission date June 2025
Expected Registration July 2026
Orphan drug No
Registration phase Clinical trials
Additional remarks Tijdslijn op basis van IHSI-inschatting.

Therapeutic value

Current treatment options Nintedanib (IPF en PPF) en Pirfenidon (IPF)
Therapeutic value No estimate possible yet
Substantiation Hoewel de voorlopige resultaten van nerandomilast veelbelovend zijn, is het op dit moment moeilijk om de effectiviteit direct te vergelijken met die van nintedanib en pirfenidon. Er zijn geen directe vergelijkende studies gedaan.
Duration of treatment lifetime
Frequency of administration 2 times a day
Dosage per administration 9mg of 18mg
References Fibroneer-IPF NCT05321069 Fibroneer-ILD NCT05321082

Expected patient volume per year

Additional remarks Op dit moment is het niet mogelijk om hier een uitspraak over te doen. Dit is afhankelijk van de resultaten van de clinical trials.

Expected cost per patient per year

Additional remarks De kosten zullen vergelijkbaar zijn met Ofev op basis van clustering (indien GVS vergoed).

Potential total cost per year

Additional remarks Op dit moment is het niet mogelijk om hier een uitspraak over te doen.

Off label use

Off label use No

Indication extension

Indication extension No

Other information

There is currently no futher information available.