EU/3/16/1638: Orphan designation for the treatment of pulmonary arterial hypertension

Ubenimex

Overview

On 21 March 2016, orphan designation (EU/3/16/1638) was granted by the European Commission to Eiger Biopharmaceuticals Europe Limited, United Kingdom, for ubenimex for the treatment of pulmonary arterial hypertension.

The sponsorship was transferred to Eigerbio Europe Limited, Ireland, in August 2019.

Key facts

Active substance
Ubenimex
Intended use
Treatment of pulmonary arterial hypertension
Orphan designation status
Positive
EU designation number
EU/3/16/1638
Date of designation
21/03/2016
Sponsor

Eigerbio Europe Limited
1 Castlewood Avenue
Rathmines
Dublin 6, D06 H685
Ireland
Tel. +1 650 272 6138
E-mail: info@eigerbio.com 

Review of designation

The Committee for Orphan Medicinal Products reviews the orphan designation of a product if it is approved for marketing authorisation.

Documents related to this orphan designation evaluation

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.

EU register of orphan medicines

The list of medicines that have received an orphan designation in the EU is available on the European Commission's website:

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