EU/3/19/2155: Orphan designation for the treatment of amyotrophic lateral sclerosis

Human culture expanded autologous mesenchymal stromal cells

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
1 Kilmainham Square
Inchicore Road
Dublin
Ireland
E-mail: emma.phelan@parexel.com

Review of designation

Update history

DateUpdate
May 2022The sponsorship was transferred to Parexel International (Irl) Limited, Ireland in April 2022.

Documents related to this orphan designation evaluation

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:

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