Expand all sections

Budesonide modified released capsule

Nefecon

Extended indication Treatment of primary immunoglobulin A (IgA) nephropathy
Therapeutic value No estimate possible yet
Registration phase Positive CHMP opinion

Product

Active substance Budesonide modified released capsule
Domain Chronic immune diseases
Reason of inclusion Indication extension
Main indication Other chronic immune diseases
Extended indication Treatment of primary immunoglobulin A (IgA) nephropathy
Proprietary name Nefecon
Manufacturer Calliditas Therapeutics
Mechanism of action Immunosuppression
Route of administration Oral
Therapeutical formulation Capsule
Budgetting framework Extramural (GVS)
Additional remarks Glucocorticoid receptor agonist

Registration

Registration route Centralised (EMA)
Type of trajectory Accelerated assessment
Submission date June 2021
Expected Registration July 2022
Orphan drug Yes
Registration phase Positive CHMP opinion
Additional remarks Positieve CHMP opinie ontvangen in mei 2022.

Therapeutic value

Current treatment options Entocort
Therapeutic value No estimate possible yet
Substantiation De werking is hetzelfde als dat van normaal budesonide. Echter, is de afgifte van de stof mogelijk beter in deze nieuwe variant. Resultaten van de studie lieten zien dat Nefecon de primaire eindpunten behaald heeft. Statistisch significant op proteinuria reductie (as measured by urine protein to creatinine ratio; P =.0005), en ook op eGFR stabilisatie (P =.0029), vergeleken met placebo.
Frequency of administration 1 times a day
Dosage per administration 16 mg
References NCT03643965

Expected patient volume per year

Patient volume

255 - 680

Market share is generally not included unless otherwise stated.
References Richtlijn Behandeling en Diagnostiek van IgA Nefropathie; Simon P, Ramee MP, Boulahrouz R et al: Epidemiologic data of primary glomerular diseases in western France. Kidney Int 66:905-908, 2004
Additional remarks De incidentie van IgA-nefropathie wordt geschat op 15-40 gevallen per miljoen inwoners. Dit zou voor Nederland betekenen dat er jaarlijks tussen de 255 en 680 patiënten in aanmerking zullen komen voor deze behandeling.

Expected cost per patient per year

Additional remarks Het is nog de vraag hoe groot het verschil in kosten zal zijn met Entocort.

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.