Extended indication Minocycline monotherapy for treatment of moderate to severe inflammatory lesions of Papulopustular rosacea in adults and elderly.
Therapeutic value No estimate possible yet
Registration phase Clinical trials

Product

Active substance Minocycline
Domain Chronic immune diseases
Reason of inclusion New medicine (specialité)
Main indication Skin diseases
Extended indication Minocycline monotherapy for treatment of moderate to severe inflammatory lesions of Papulopustular rosacea in adults and elderly.
Manufacturer Journey Medical
Portfolio holder Journey Medical
Mechanism of action Antibiotic
Route of administration Oral
Therapeutical formulation Tablet
Budgetting framework Extramural (GVS)

Registration

Registration route Centralised (EMA)
Type of trajectory Normal trajectory
Submission date August 2025
Expected Registration September 2026
Registration phase Clinical trials

Therapeutic value

Therapeutic value No estimate possible yet

This assessment does not indicate any potential inclusion in the package.

Expected patient volume per year

Patient volume

Market share is generally not included unless otherwise stated.

References NHG-Standaard Rosacea (2019); CBS bevolkingsdata; Two et al., J Am Acad Dermatol, 2015.
Additional remarks Ongeveer 5% van de Nederlandse volwassenen heeft rosacea, waarvan circa 30 tot 40% papulopustuleuze rosacea. Hiervan heeft naar schatting 20 tot 30% matige tot ernstige vormen die in aanmerking komen voor systemische therapie. Dit betekent dat jaarlijks ongeveer 40.000 tot 75.000 patiënten in Nederland mogelijk behandeld worden met orale middelen zoals minocycline.

Expected cost per patient per year

Potential total cost per year

Off label use

Indication extension

Other information