On 20 October 2003, orphan designation (EU/3/03/168) was granted by the European Commission to MolMed SpA, Italy, for herpes simplex 1 virus-thymidine kinase and truncated low affinity nerve growth factor receptor transfected donor lymphocytes for the adjunctive treatment of haematopoietic cell transplantation.
Herpes simplex 1 virus-thymidine kinase and truncated low affinity nerve growth factor receptor transfected donor lymphocytes was authorised in the EU as Zalmoxis on 18 August 2016.
The marketing authorisation was withdrawn on 11 October 2019.
Please note that this product was withdrawn from the Community Register of designated orphan medicinal products by the European Commission in October 2019 at the time of withdrawal of the marketing authorisation.
EU/3/03/168: Public summary of positive opinion for orphan designation of herpes simplex 1 virus-thymidine kinase and truncated low affinity nerve growth factor receptor transfected donor lymphocytes (PDF/303.49 KB)
First published: 04/01/2006
Last updated: 04/01/2006
Herpes simplex 1 virus-thymidine kinase and truncated low affinity nerve growth factor receptor transfected donor lymphocytes
|Disease / condition||
Adjunctive treatment in haematopoietic cell transplantation
|Date of first decision||
|EU designation number||
Review of designation
On 28 June 2016, the Committee for Orphan Medicinal Products (COMP) completed its review of the designation EU/3/03/168 for Zalmoxis (allogeneic T cells genetically modified with a retroviral vector encoding for a truncated form of the human low affinity nerve growth factor receptor (ΔLNGFR) and the herpes simplex I virus thymidine kinase (HSV-TK Mut2))1 as an orphan medicinal product for the adjunctive treatment of haematopoietic stem cell transplantation. The COMP assessed whether, at the time of marketing authorisation, the medicinal product still met the criteria for orphan designation. The Committee looked at the seriousness and prevalence of the condition, and the existence of other methods of treatment. As other methods of treatment are authorised in the European Union (EU), the COMP also considered whether the medicine is of significant benefit to patients undergoing haematopoietic stem cell transplantation. The COMP recommended that the orphan designation of the medicine be maintained2.
1 Previously known as 'herpes simplex 1 virus-thymidine kinase and truncated low affinity nerve growth factor receptor transfected donor lymphocytes'.
2 The maintenance of the orphan designation at time of marketing authorisation would, except in specific situations, give an orphan medicinal product 10 years of market exclusivity in the EU. This means that in the 10 years after its authorisation similar products with the same therapeutic indication cannot be placed on the market.
Sponsor's contact details
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.