EU/3/20/2392: Orphan designation for the treatment of dermatomyositis

Humanised IgG1K monoclonal antibody against interferon beta

Overview

On 6 January 2021, orphan designation EU/3/20/2392 was granted by the European Commission to Pfizer Europe MA EEIG, Belgium, for humanised IgG1K monoclonal antibody against interferon beta (also known as PF-06823859) for the treatment of dermatomyositis.

Key facts

Active substance
Humanised IgG1K monoclonal antibody against interferon beta
Intended use
Treatment of dermatomyositis
Orphan designation status
Positive
EU designation number
EU/3/20/2392
Date of designation
06/01/2021
Sponsor

Pfizer Europe MA EEIG
Boulevard de la Plaine 17
1050 Bruxelles
Brussels-Capital Region
Belgium
E-mail: orphan_enquiries@pfizer.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:

  • 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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