EU/3/15/1582

About

On 11 November 2015, orphan designation (EU/3/15/1582) was granted by the European Commission to The Chancellor, Masters and Scholars of the University of Oxford, United Kingdom, for humanised monoclonal antibody of the IgG4 kappa isotype targeting CD47 for the treatment of acute myeloid leukaemia.

The sponsorship was transferred to ICON Clinical Research Limited, Ireland, in June 2016.

The sponsorship was transferred to ICON Clinical Research Limited, Ireland, in June 2016 and subsequently to Gilead Sciences Ireland UC, Ireland, in September 2020.

This medicine is now known as magrolimab.

Key facts

Active substance
humanised monoclonal antibody of the IgG4 kappa isotype targeting CD47 (magrolimab)
Disease / condition
Treatment of acute myeloid leukaemia
Date of first decision
11/11/2015
Outcome
Positive
EU designation number
EU/3/15/1582

Review of designation

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

Sponsor's contact details

Gilead Sciences Ireland UC
Carrigtohill
County Cork
T45 DP77
Ireland
Tel:  +353 21 48 25500
E-mail: regulatory.orphan@gilead.com

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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