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Polihexanide

Extended indication Acanthamoeba keratitis in patients aged 13 years and older.
Therapeutic value No estimate possible yet
Registration phase Clinical trials

Product

Active substance Polihexanide
Domain Neurological disorders
Reason of inclusion New medicine (specialité)
Main indication Eye disorders
Extended indication Acanthamoeba keratitis in patients aged 13 years and older.
Manufacturer SIFI
Mechanism of action Disinfectant
Route of administration Ocular
Therapeutical formulation Eye drops
Budgetting framework Extramural (GVS)
Additional remarks Disinfectant that is active against bacteria and acanthamoeba.

Registration

Registration route Centralised (EMA)
Submission date 2021
Expected Registration 2022
Orphan drug Yes
Registration phase Clinical trials

Therapeutic value

Current treatment options De behandeling bestaat uit oogdruppels met een ontsmettende werking, zoals chloorhexidine, brolene of PHMB.
Therapeutic value No estimate possible yet
Substantiation Het wordt gebruikt als vervanging van chloorhexidine, maar het is nog onduidelijk wat de verwachte waarde is ten opzichte van chloorhexidine.
References NCT03274895
Additional remarks Clinical trial: 16 drops each in a day for 5 days,8 drops each in a day for 7 days,6 drops each in a day for 7 days and 4 drops each in a day up to clinical resolution.

Expected patient volume per year

Patient volume

< 100

Market share is generally not included unless otherwise stated.
References SPS, https://www.radboudumc.nl/patientenzorg/aandoeningen/acanthamoebe-keratitis/
Additional remarks SPS: "Acanthamoeba keratitis is a form of keratitis with a fairly low prevalence (7 cases per 1,000,000 in Europe)". Teruggerekend naar Nederland gaat dat om maximaal 119 personen. Op de website van het Radboud UMC is het volgende terug te vinden: in Nederland komt acanthamoebe-keratitis weinig voor, 30 tot 40 keer per jaar. Dit aantal lijkt toe te nemen. De inschatting is dat minder dan 100 patiënten per jaar die in aanmerking zullen komen voor dit geneesmiddel.

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

Indication extension No

Other information

There is currently no futher information available.