EU/3/20/2301: Orphan designation for the treatment of acute respiratory distress syndrome (ARDS)

Pegylated adrenomedullin

Overview

On 27 July 2020, orphan designation EU/3/20/2301 was granted by the European Commission to Bayer AG, Germany, for pegylated adrenomedullin (also known as PEG-ADM or BAY 1097761) for the treatment of acute respiratory distress syndrome.

Key facts

Active substance
Pegylated adrenomedullin
Intended use
Treatment of acute respiratory distress syndrome (ARDS)
Orphan designation status
Positive
EU designation number
EU/3/20/2301
Date of designation
27/07/2020
Sponsor

Bayer AG
51368 Leverkusen
Germany
E-mail: clinical-trials-contact@bayer.com

Review of designation

The Committee for Orphan Medicinal Products reviews the orphan designation of a product if it is approved for marketing authorisation.

Update history

DateUpdate
December 2022The sponsor’s address was updated.

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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