EU/3/20/2319
Table of contents
About
On 21 August 2020, orphan designation EU/3/20/2319 was granted by the European Commission to Scendea (NL) B.V, Netherlands, for sodium (4-{(E)-3-(4-fluorophenyl)-3-[4-(3-morpholin-4-yl-prop1ynyl)phenyl]allyloxy}-2-methylphenoxy)acetate (also known as REN001) for the treatment of long-chain 3-hydroxyacyl-CoA dehydrogenase deficiency.
Key facts
Active substance |
Sodium (4-{(E)-3-(4-fluorophenyl)-3-[4-(3-morpholin-4-yl-prop1ynyl)phenyl]allyloxy}-2-methylphenoxy)acetate
|
Disease / condition |
Treatment of long-chain 3-hydroxyacyl-coenzyme A dehydrogenase deficiency
|
Date of first decision |
21/08/2020
|
Outcome |
Positive
|
EU designation number |
EU/3/20/2319
|
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
Scendea (NL) B.V.
De Cuserstraat 93
1081 CN Amsterdam
Noord-Holland
The Netherlands
Tel. +31 2089 49169
E-mail: orphan@scendea.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.