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Nature Reviews Drug Discovery | Published online 2 Feb 2017
N E W S & A N A LY S I S
NEWS IN BRIEF
2016 EMA drug approval recommendations
The European Medicines Agency (EMA) recommended approval for http://www.ema.europa.eu/docs/en_GB/document_library/Leaflet/2017/01/WC500219736.pdf
Web End =27 new therapeutic agents in 2016, down from 39 in 2015 and 40 in 2014.
The EMAs count includes small molecules, antibodies, biologics, blood products, cellular therapies and vaccines, and so cannot be compared directly with approvals from the FDAs Center for Drug Evaluation and Research (CDER), which reviews only small molecules and some types of biologic. However, CDER also approved fewer products in 2016 than in previous years (see http://www.nature.com/nrd/journal/v16/n2/full/nrd.2017.14.html
Web End =Nat. Rev. Drug Discov. 16, 7376; 2017 ).
Most of the new EMA green lights went to therapeutics that the FDA approved in 2015 or 2016. There were a few notable differences, including approvals for two advanced cellular therapies that have not yet been approved by the FDA.
GlaxoSmithKlines strimvelis is the second gene therapy to be approved in Europe (http://www.nature.com/nrd/journal/v15/n5/full/nrd.2016.93.html
Web End =Nat. Rev. http://www.nature.com/nrd/journal/v15/n5/full/nrd.2016.93.html
Web End =Drug Discov. 15, 299; 2016 ). Strimvelis is an autologous gene therapy for severe combined immunodeficiency due to adenosine deaminase deficiency (ADA-SCID). It is produced by collecting a patients bone marrow cells and transducing these cells ex vivo with a viral vector so that they express adenosine deaminase (ADA).
The EMA also approved MolMeds zalmoxis, which consists of allogeneic T cells that have been genetically modified to carry a truncated form of the human low-affinity nerve growth factor receptor...