On 10 July 2007, orphan designation (EU/3/07/456) was granted by the European Commission to Regeneron UK Limited, United Kingdom, for rilonacept for the treatment of cryopirin-associated periodic syndromes (familial cold urticaria syndrome (FCUS), Muckle-Wells syndrome (MWS) and neonatal onset multisystem inflammatory disease (NOMID), also known as chronic infantile neurological cutaneous articular syndrome (CINCA)).
Rilonacept was authorised in the EU as Rilonacept Regeneron (previously Arcalyst) on 23 October 2009.
The marketing authorisation was withdrawn on 24 October 2012.
Please note that this product was withdrawn from the Community Register of designated orphan medicinal products by the European Commission in October 2012 at the time of withdrawal of the marketing authorisation.
EU/3/07/456: Public summary of positive opinion for orphan designation of rilonacept for the treatment of cryopirin-associated periodic syndromes (Familial Cold Urticaria Syndrome (FCUS), Muckle-Wells Syndrome (MWS), and... (PDF/174.63 KB)
First published: 29/07/2008
Last updated: 17/10/2014
|Disease / condition||
Treatment of cryopirin-associated periodic syndromes
|Date of decision||
|Orphan decision number||
Sponsor's contact details
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London, E14 5DS
Telephone: + 44 20 7519 70 59
Telefax: + 44 20 7519 70 59
For contact details of patients’ organisations whose activities are targeted at rare diseases, see:
- European Organisation for Rare Diseases (EURORDIS), a non-governmental alliance of patient organisations and individuals active in the field of rare diseases.
- Orphanet, a database containing information on rare diseases, which includes a directory of patients’ organisations registered in Europe;