GMO medicinal products for human use
The first application for authorisation for the placing on the market of a medicinal product for human use consisting of a GMO was filed with the EMA in 2005. This dossier related to a recombinant adenovirus developed to treat cancers. Other dossiers have been submitted since then and examined by the Biosafety Advisory Council as part of the Member State consultation procedure.
Start of procedure | Treatment type | GMO type |
---|---|---|
2005 | Treatment against cancer | GM adenovirus |
2007 | Treatment against cancer | GM adenovirus |
2008 | Treatment against cancer | GM adenovirus |
2008 | Treatment against cancer | GM adenovirus |
2008 | Anti-flu vaccine | Attenuated influenza virus |
2010 | Treatment of rare human genetic disorder | GM adenovirus |
2014 | Treatment against cancer | GM T-cells with retrovirus |
2015 | Anti-flu vaccine | Attenuated influenza virus |
2015 | Treatment of severe immunodeficiency | CD34+ cells transduced with retrovirus |
2016 | Dengue virus vaccine | Attenuated GM virus |
2017 | Treatment of vision loss | GM adeno-associated virus |
2017 | Treatment of lymphoma | Autologous cell therapy |
2017 | Treatment against cancer | Autologous cell therapy |
2018 | Treatment against cancer (application withdrawn 27/07/2018) | GM bacteria |
2018 | Treatment against beta-thalassemia | Autologous cell therapy |
2018 | Treatment of human genetic disorder | GM adeno-associated virus |
2019 | Cholera vaccine | GM bacteria |
2019 | Ebola virus vaccine | GM vesicular stomatitis virus |
Table: GMO medicinal products for human use - Dossiers submitted at European level and assessed by the Biosafety Advisory Council
Ten products have been granted a marketing authorisation in the EU so far (for more details on the product and the authorisation procedure click on the corresponding link):
- Fluenz (27/01/2011) - withdrawn on 03/12/2014 and replaced by Fluenz Tetra (04/12/2013)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)
- Pandemic influenza vaccine H5N1 (20/05/2016)
- Zalmoxis (18/08/2016)
- Strimvelis (26/05/2016)
- Kymriah (22/08/2018)
- Yescarta (23/08/2018)
- Luxturna (22/11/2018)
- Dengvaxia (12/12/2018)
- Zynteglo (29/05/2019)
GMO medicinal products for veterinary use
Up to now, nineteen GMO medicinal products for veterinary use have been granted a marketing authorisation in the EU. Sixteen of these products are vaccines, one is a treatment against cancer (Oncept IL-2).
Two of them were authorised under Directive 90/220/EEC:
- A vaccine against the porcine Aujeszky disease (genetically modified virus), authorised in December 1992 (authorisation amended in July 1994 – Decision 94/505/EC – to cover a new form of administration);
- The Raboral recombinant vaccine for preventing rabies in foxes (see text box on the right), authorised in October 1993 (Decision 93/572/EEC).
The other products have been processed under Regulation (EEC) No. 2309/93 (between 1993 and 2004) or under Regulation (EC) 726/2004.
All these GMO medicinal products for veterinary use are listed below in alphabetical order with the corresponding date of authorisation. For more details on the product and the authorisation procedure click on the corresponding link.
- Bovela (22/12/2014)
- Equilis StrepE (07/05/2004)
- Hiprabovis IBR marker live (27/01/2011)
- Innovax-ILT (03/07/2015)
- Nobivac Myxo-RHD (07/09/2011)
- Nobi-Porvac Aujeszky (18/12/1992 & 18/07/1994)
- Oncept IL-2 (03/05/2013)
- Poulvac E. coli (15/06/2012)
- ProteqFLU (6/03/2003)
- ProteqFLU-Te (6/03/2003)
- Proteq West Nile (5/08/2011)
- Purevax FeLV (formerly Eurifel FeLV) (13/04/2000 - withdrawn in 2007 - no renewal requested)
- Purevax rabies (18/02/2011)
- Purevax RCP FeLV (formerly Eurifel RCP FelV) (08/03/2002)
- Raboral V-RG (19/10/1993)
- Suvaxyn Aujeszky (07/08/1998)
- Suvaxyn CSF Marker (10/02/2015)
- Vaxxitek HVT + IBD (formerly Gallivac HVT IBD) (9/08/2002)
- Vectormune (08/09/2015)