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.
human monoclonal antibody against activin A
Treatment of fibrodysplasia ossificans progressiva
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Documents related to this orphan designation evaluation
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: