EU/3/15/1489: Orphan designation for the treatment of myasthenia gravis

Fusion proteins composed by a genetically modified cholera toxin subunit A1, peptides from the acetylcholine receptor alpha chain and a dimer of the D fragment from Staphylococcus aureus protein A

Overview

On 21 May 2015, orphan designation (EU/3/15/1489) was granted by the European Commission to Toleranzia AB, Sweden, for fusion proteins composed by a genetically modified cholera toxin subunit A1, peptides from the acetylcholine receptor alpha chain and a dimer of the D fragment from Staphylococcus aureus protein A for the treatment of myasthenia gravis.

Please note that this product was withdrawn from the Community Register of designated Orphan Medicinal Products in April 2019 on request of the Sponsor.

Key facts

Active substance
Fusion proteins composed by a genetically modified cholera toxin subunit A1, peptides from the acetylcholine receptor alpha chain and a dimer of the D fragment from Staphylococcus aureus protein A
Intended use
Treatment of myasthenia gravis
Orphan designation status
Withdrawn
EU designation number
EU/3/15/1489
Date of designation
21/05/2015
Sponsor

Toleranzia AB
Arvid Wallgrens backe 20, 8th floor
413 46 Goteborg
Sweden
Tel. +46 704 566 441
Fax +46 317 865 150
E-mail: martina.verolin@toleranzia.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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