EU/3/19/2182: Orphan designation for the treatment of primary biliary cholangitis

Elafibranor

Overview

On 25 July 2019, orphan designation EU/3/19/2182 was granted by the European Commission to Genfit, France, for elafibranor for the treatment of primary biliary cholangitis.

Key facts

Active substance
Elafibranor
Intended use
Treatment of primary biliary cholangitis
Orphan designation status
Positive
EU designation number
EU/3/19/2182
Date of designation
25/07/2019
Sponsor

Genfit
Parc Eurasante Lille Metropole
885 Avenue Eugene Avinee
59120 Loos
France
Tel. +33(0) 3 20 16 40 00
E-mail: eric.marthinet@genfit.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:

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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