EU/3/17/1856: Orphan designation for the treatment of neuromyelitis optica spectrum disorders

Inebilizumab

Overview

On 20 March 2017, orphan designation (EU/3/17/1856) was granted by the European Commission to AstraZeneca AB, Sweden, for inebilizumab (also known as MEDI-551) for the treatment of neuromyelitis optica spectrum disorders.

The sponsorship was transferred to Quality Regulatory Clinical Ireland Ltd, Ireland, in September 2018.

The sponsorship was transferred Viela Bio B.V., Netherlands in November 2020.

Please note that this product (marketed as Uplizna) was withdrawn from the Union Register of orphan medicinal products by the European Commission in March 2022 at the time of the granting of a marketing authorisation.

Key facts

Active substance
Inebilizumab
Intended use
Treatment of neuromyelitis optica spectrum disorders
Orphan designation status
Withdrawn
EU designation number
EU/3/17/1856
Date of designation
20/03/2017
Sponsor

Viela Bio B.V.
Schiphol Boulevard 359
1118 BJ Schiphol
Netherlands
Email: info@vielabio.com

Review of designation

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

The Committee for Orphan Medicinal Products reviewed the orphan designation of Uplizna at the time of marketing authorisation, and recommended that the orphan designation should not be maintained.

More information is available in the orphan medicine assessment report.

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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