Marketing authorisations for GMO-medicinal products for human use

Ten products have received marketing authorisation so far (for more details on the product and the authorisation procedure click on the corresponding link):

  • Dengvaxia (12/12/2018)
  • Fluenz (27/01/2011) - withdrawn on 03/12/2014 and replaced by Fluenz Tetra (04/12/2013)
  • Glybera (25/10/2012)
  • Imlygic (16/12/2015)
  • Kymriah (22/08/2018)
  • Luxturna (22/11/2018)
  • Pandemic influenza vaccine H5N1 AstraZeneca (previously Pandemic influenza vaccine H5N1 Medimmune)(20/05/2016)
  • Zalmoxis (18/08/2016)
  • Strimvelis (26/05/2016)
  • Yescarta (23/08/2018)

 

Fluenz (now replaced by Fluenz Tetra)
Application number EMEA/H/C/001101
Marketing authorisation holder MedImmune LLC
Name of the product Fluenz
Active substances Influenza virus reassortants
Parental organism Life attenuated strain of Influenza virus
Transgene(s) Influenza virus reassortants for each of the 3 strains selected for the yearly season
Treated organism Humans: children en adolescents
Indication(s) Vaccination against influenza A (subtypes H1N1 and H3N2) and influenza B
Administration route(s) Nasal spray
Type of authorisation Centralised at European level
Legal frame Council regulation (EC) No 726/2004 and the environmental safety requirements laid down by European Directive 2001/18/EC, part C and the Royal Decree of 21/02/2005, article 27
Competent authority EMA/European Commission
Belgian advisory body Biosafety Advisory Council
Date of the advices of the Biosafety Advisory Council 08/04/2009, 17/06/2010, 13/09/2010
EMA (CHMP) opinion (date) Positive (27/10/2010)
European Commission authorisation number (date) EU/1/10/661 (27/01/2011)
European Commission decision Community register of medicinal products
European Public Assessment Report (including EMA opinion, Product information leaflet and Summary of product characteristics in all EU languages) EPAR (link to Web site of EMA)
Notifications to Belgian authorities while in Research and Development stage None

 

Glybera
Application number EMEA/H/C/2145
Marketing authorisation holder uniQure biopharma B.V.
Name of the product Glybera
Active substances Viral vector
Parental organism Protein shell deived from adeno-associated virus serotype 1
Transgene(s) Human lipoprotein lipase
Treated organism Humans: adults
Indication(s) Lipoprotein lipase deficiency (LPLD)
Administration route(s) Intramuscular
Type of authorisation Centralised at European level
Legal frame Council regulation (EC) No 726/2004 and the environmental safety requirements laid down by European Directive 2001/18/EC, part C and the Royal Decree of 21/02/2005, article 27
Competent authority EMA/European Commission
Belgian advisory body Biosafety Advisory Council
Date of the advices of the Biosafety Advisory Council 30/04/2010, 10/01/2011, 09/05/2011
EMA (CHMP) opinion (date) Positive (19/07/2012)
European Commission authorisation number (date) EU/1/12/791 (25/10/2012) - with restricted access programme
European Commission decision Community register of medicinal products
European Public Assessment Report (including EMA opinion, Product information leaflet and Summary of product characteristics in all EU languages) EPAR (link to Web site of EMA)
Notifications to Belgian authorities while in Research and Development stage None

 

Imlygic
Application number EMEA/H/C/002771
Marketing authorisation holder Amgen Europe B.V.
Name of the product Imlygic
Active substances Talimogene laherparepvec (oncolytic virus)
Parental organism Herpes simplex virus 1
Transgene(s) Immune stimulatory protein human GM-CSF
Treated organism Humans: adults
Indication(s) Treatment of melanomas
Administration route(s) Injection into melanoma tumours
Type of authorisation Centralised at European level
Legal frame Council regulation (EC) No 726/2004 and the environmental safety requirements laid down by European Directive 2001/18/EC, part C and the Royal Decree of 21/02/2005, article 27
Competent authority EMA/European Commission
Belgian advisory body Biosafety Advisory Council
Date of the advice of the Biosafety Advisory Council Not assesed by the Council
EMA (CHMP) opinion (date) Positive (22/10/2015)
European Commission authorisation number (date) EU/1/15/1064 (16/12/2015)
European Commission decision Community register of medicinal products
European Public Assessment Report (including EMA opinion, Product information leaflet and Summary of product characteristics in all EU languages) EPAR (link to Web site of EMA)
Notifications to Belgian authorities while in Research and Development stage B/BE/14/BVW1, B/BE/15/BVW1 (links to the Belgian Biosafety Server)

 

Zalmoxis
Application number EMEA/H/C/2801
Marketing authorisation holder MolMed S.p.A.
Name of the product Zalmoxis
Active substances Allogeneic T cells
Parental organism T-cells obtained from haploidentical donors
Transgene(s) Truncated form of the human low affinity nerve growth factor receptor and the herpes simplex I virus thymidine kinase
Treated organism Humans: adults
Indication(s) Adjunctive treatment in haploidentical haematopoietic stem cell transplantation (HSCT) of adult patients with high-risk haematological malignancies
Administration route(s) Intravenous infusion following cell thawing
Type of authorisation Centralised at European level
Legal frame Council regulation (EC) No 726/2004 and the environmental safety requirements laid down by European Directive 2001/18/EC, part C and the Royal Decree of 21/02/2005, article 27
Competent authority EMA/European Commission
Belgian advisory body Biosafety Advisory Council
Date of the advices of the Biosafety Advisory Council 11/03/2015, 12/01/2016, 21/03/2016
EMA (CHMP) opinion (date) Positive (24/06/2016)
European Commission authorisation number (date) EU/1/16/1121 (18/08/2016)
European Commission decision Community register of medicinal products
European Public Assessment Report (including EMA opinion, Product information leaflet and Summary of product characteristics in all EU languages) EPAR (link to Web site of EMA)
Notifications to Belgian authorities while in Research and Development stage None

 

Strimvelis
Application number EMEA/H/C/003854
Marketing authorisation holder GlaxoSmithKline Trading Services Limited
Name of the product Strimvelis
Active substances autologous CD34+ enriched cell fraction that contains CD34+ cells transduced with retroviral vector that encodes for the human ADA cDNA sequence
Parental organism CD34+ cells extracted from the patient’s bone marrow
Transgene(s) Human adenosine deaminase (ADA)
Treated organism Humans: adults
Indication(s) Severe combined immunodeficiency due to adenosine deaminase deficiency (ADA-SCID)
Administration route(s) Intravenous infusion
Type of authorisation Centralised at European level (orphan status)
Legal frame Council regulation (EC) No 726/2004 and the environmental safety requirements laid down by European Directive 2001/18/EC, part C and the Royal Decree of 21/02/2005, article 27
Competent authority EMA/European Commission
Belgian advisory body Biosafety Advisory Council
Date of the advices of the Biosafety Advisory Council 08/09/2015, 15/02/2016
EMA (CHMP) opinion (date) Positive (01/04/2016)
European Commission authorisation number (date) EU/1/16/1097 (26/05/2016)
European Commission decision Community register of medicinal products
European Public Assessment Report (including EMA opinion, Product information leaflet and Summary of product characteristics in all EU languages) EPAR (link to Web site of EMA)
Notifications to Belgian authorities while in Research and Development stage None