EU/3/14/1345

About

On 15 October 2014, orphan designation (EU/3/14/1345) was granted by the European Commission to Novartis Europharm Ltd, United Kingdom, for osilodrostat for the treatment of Cushing's syndrome.

The sponsorship was transferred to Novartis Europharm Limited, Ireland in May 2018.

Osilodrostat has been authorised in the EU as Isturisa since 9 January 2020.

The sponsorship was transferred to Recordati Rare Diseases, France in March 2020.

Key facts

Active substance
Osilodrostat
Disease / condition
Treatment of Cushing's syndrome
Date of first decision
15/10/2014
Outcome
Positive
EU designation number
EU/3/14/1345

Review of designation

The Committee for Orphan Medicinal Products reviewed the orphan designation of Isturisa at the time of marketing authorisation, and confirmed that the orphan designation should be maintained. 

More information is available in the PDF iconorphan medicine assessment report .

Sponsor's contact details

Recordati Rare Diseases   
Immeuble Le Wilson
70 Avenue Du General De Gaulle
92800 Puteaux
France
Tel. +33 1 4773 9527
E-mail: RRDinfo@recordati.com

Patients' organisations

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.

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