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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.

Key facts

Active substance
human monoclonal antibody against activin A
Disease / condition
Treatment of fibrodysplasia ossificans progressiva
Date of first decision
EU designation number

Sponsor's contact details

Regeneron Ireland DAC
Europa House
Harcourt Centre
Harcourt Street
Dublin 2
Tel. +353 (0)1 411 2200

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.

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