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Avacopan

Extended indication Treatment of patients with active ANCA-associated vasculitis (including granulomatosis with polyangi
Therapeutic value No judgement
Registration phase Registration application pending

Product

Active substance Avacopan
Domain Chronic immune diseases
Main indication Cardiovascular diseases
Extended indication Treatment of patients with active ANCA-associated vasculitis (including granulomatosis with polyangiitis and microscopic polyangiitis).
Manufacturer ChemoCentryx
Route of administration Oral
Therapeutical formulation Capsule
Budgetting framework Extramural (GVS)

Registration

Registration route Centralised (EMA)
Particularity New medicine with Priority Medicines (PRIME)
Submission date January 2018
Expected Registration February 2019
Orphan drug Yes
Registration phase Registration application pending
Additional remarks PRIME-status sinds mei 2016.

Therapeutic value

Current treatment options EMA: 'At the time of orphan designation, no satisfactory treatments were authorised in the EU for C3 glomerulopathy.'
Therapeutic value No judgement

Expected patient volume per year

Patient volume

< 2,720

Market share is generally not included unless otherwise stated.
References EMA
Additional remarks EMA Orphan designation: 'At the time of designation granulomatosis with polyangiitis affected approximately 1.6 in 10,000 people in the European Union (EU).'

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

There is currently nothing known about indication extensions.

Other information

There is currently no futher information available.