EU/3/13/1108: Orphan designation for the treatment of systemic sclerosis

2-[4-Methoxy-3-(2-m-tolyl-ethoxy)-benzoylamino]-indan-2-carboxylic acid


On 12 March 2013, orphan designation (EU/3/13/1108) was granted by the European Commission to Sanofi-Aventis Groupe, France, for 2-[4-methoxy-3-(2-m-tolyl-ethoxy)-benzoylamino]-indan-2-carboxylic acid for the treatment of systemic sclerosis.

The sponsorship was transferred to Horizon Therapeutics Ireland Designated Activity Company in September 2020.

Key facts

Active substance
2-[4-Methoxy-3-(2-m-tolyl-ethoxy)-benzoylamino]-indan-2-carboxylic acid
Intended use
Treatment of systemic sclerosis
Orphan designation status
EU designation number
Date of designation

Horizon Therapeutics Ireland Designated Activity Company
1st floor Connaught House
1 Burlington Road
Dublin 4 D04 C5Y6

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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