EU/3/16/1801: Orphan designation for the treatment of amyotrophic lateral sclerosis



On 12 December 2016, orphan designation (EU/3/16/1801) was granted by the European Commission to MediciNova (Europe) Limited, United Kingdom, for ibudilast for the treatment of amyotrophic lateral sclerosis.

The sponsorship was transferred to Medicinova Europe GmbH, Germany, in October 2019.

Key facts

Active substance
Intended use
Treatment of amyotrophic lateral sclerosis
Orphan designation status
EU designation number
Date of designation

Medicinova Europe GmbH
Leopoldstrasse 16 
Schwabing Freimann 
80802 Munich 

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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