EU/3/16/1779: Orphan designation for the treatment of fibrodysplasia ossificans progressiva

human monoclonal antibody against activin A

Table of contents

Overview

On 18 November 2016, orphan designation (EU/3/16/1779) was granted by the European Commission to Regeneron Ireland, Ireland, for human monoclonal antibody against activin A (also known as REGN2477) for the treatment of fibrodysplasia ossificans progressiva.

In January 2018, Regeneron Ireland changed name to Regeneron Ireland U.C.

In December 2019, Regeneron Ireland U.C. changed name to Regeneron Ireland DAC.

The sponsor’s address was updated in October 2021.

Key facts

Active substance
human monoclonal antibody against activin A
Intended use
Treatment of fibrodysplasia ossificans progressiva
Orphan designation status
Positive
EU designation number
EU/3/16/1779
Date of designation
18/11/2016
Sponsor

Regeneron Ireland DAC
One Warrington Place
Dublin 2
Co. Dublin
D02 HH27
Ireland
Tel: +353 (0)1 411 2200
E-mail: eu-regaffairs@regeneron.com

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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