EU/3/15/1582
Table of contents
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.