EU/3/19/2155: Orphan designation for the treatment of amyotrophic lateral sclerosis
Human culture expanded autologous mesenchymal stromal cells
Table of contents
Overview
On 24 April 2019, orphan designation (EU/3/19/2155) was granted by the European Commission to IQVIA RDS Ireland Limited, Ireland, for human culture expanded autologous mesenchymal stromal cells (also known as lenzumestrocel) for the treatment of amyotrophic lateral sclerosis.
Key facts
Active substance |
Human culture expanded autologous mesenchymal stromal cells
|
Intended use |
Treatment of amyotrophic lateral sclerosis
|
Orphan designation status |
Positive
|
EU designation number |
EU/3/19/2155
|
Date of designation |
24/04/2019
|
Sponsor |
Parexel International (Irl) Limited |
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
Date | Update |
---|---|
May 2022 | The sponsorship was transferred to Parexel International (Irl) Limited, Ireland in April 2022. |
Patients' organisations
For contact details of patients’ organisations whose activities are targeted at rare diseases, see:
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: