Autorisations de commercialisation d'OGM médicinaux à usage humain

Dix médicaments ont reçu à ce jour une autorisation de mise sur le marché au niveau européen (pour de plus amples informations sur un produit et la procédure d’autorisation, veuillez cliquer sur le lien correspondant):

 

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 Live 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)

 

Pandemic Influenza vaccine H5N1 AstraZeneca
Application number EMEA/H/C/003963
Marketing authorisation holder AstraZeneca AB 
Name of the product Pandemic Influenza vaccine H5N1 Astra Zeneca 
Active substances Pandemic Influenza vaccine H5N1 (live attenuated, nasal)
Parental organism Live attenuated influenza A virus A/Vietnam/1203/2004 (H5N1) strain
Transgene(s)  
Treated organism Humans: children and adolescents
Indication(s) Prophylaxis of influenza in an officially declared pandemic situation in children and adolescents from 12 months to less than 18 years of age
Administration route(s) Intranasal route 
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 advice of the Biosafety Advisory Council None
EMA (CHMP) opinion (date) Positive (01/04/2016)
European Commission authorisation number (date) EU/1/16/1089 (20/05/2016)
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

 

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

 

Kymriah
Application number EMEA/H/C/004090
Marketing authorisation holder Novartis Europharm Limited 
Name of the product Kymriah
Active substances Tisagenlecleucel, autologous T cells transduced with lentiviral vector containing a chimeric antigen receptor directed against CD19. 
Parental organism Autologous T cells 
Transgene(s) Chimeric antigen receptor directed against CD19 
Treated organism Humans: adults
Indication(s) Paediatric and young adult patients up to 25 years of age with B cell acute lymphoblastic leukaemia (ALL) that is refractory, in relapse post transplant or in second or later relapse. Adult patients with relapsed or refractory diffuse large B cell lymphoma (DLBCL) after two or more lines of systemic therapy
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 advice of the Biosafety Advisory Council 01/03/2018, 18/05/2018
EMA (CHMP) opinion (date) Positive (28/06/2018)
European Commission authorisation number (date) EU/1/18/1297 (22/08/2018)
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

 

Yescarta
Application number EMEA/H/C/004480
Marketing authorisation holder Kite Pharma EU B.V
Name of the product Yescarta
Active substances Axicabtagene ciloleucel, autologous T cells genetically modified to express a chimeric antigen receptor against CD19
Parental organism Autologous T cells
Transgene(s) Chimeric antigen receptor targeting CD19
Treated organism Humans: adults
Indication(s) Treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) and primary mediastinal large B-cell lymphoma (PMBCL), after two or more lines of systemic therapy
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 advice of the Biosafety Advisory Council 30/11/2017, 06/04/2018, 20/06/2018
EMA (CHMP) opinion (date) Positive (28/06/2018)
European Commission authorisation number (date) EU/1/18/1299 (23/08/2018)
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

 

Luxturna
Application number EMEA/H/C/004451
Marketing authorisation holder Novartis Europharm Limited
Name of the product Luxturna
Active substances Voretigene neparvovec, recombinant adeno-associated virus serotype 2 harbouring the human retinal pigment epithelium protein gene (RPE 65
Parental organism Replication defective recombinant adeno-associated virus serotype 2 
Transgene(s) Human retinal pigment epithelium-specific 65 kDA protein gene (RPE65
Treated organism Humans: adult and paediatric patients
Indication(s) Treatment of adult and paediatric patients with vision loss due to inherited retinal dystrophy caused by confirmed biallelic RPE65 mutations and who have sufficient viable retinal cells
Administration route(s) Subretinal injection 
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 advice of the Biosafety Advisory Council 27/11/2017, 30/04/2018, 11/07/2018
EMA (CHMP) opinion (date) Positive (20/09/2018)
European Commission authorisation number (date) EU/1/18/1331 (22/11/2018)
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

 

Dengvaxia
Application number EMEA/H/C/004171
Marketing authorisation holder Sanofi Pasteur
Name of the product Dengvaxia
Active substances Dengue tetravalent vaccine (live, attenuated)
Parental organism Attenuated yellow fever vaccine strain 
Transgene(s) Each chimeric yellow fever dengue virus contains the prM and E genes from each of the dengue virus serotypes 1,2,3 and 4
Treated organism Humans: adults
Indication(s) Prevention of dengue disease caused by dengue virus serotypes 1, 2, 3 and 4 in individuals 9 to 45 years of age with prior dengue virus infection and living in endemic areas
Administration route(s) Subcutaneous route
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 advice of the Biosafety Advisory Council 24/05/2015, 31/01/2017, 31/03/2018
EMA (CHMP) opinion (date) Positive (18/10/2018)
European Commission authorisation number (date) EU/1/18/1338 (12/12/2018)
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