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N E W S & A N A LY S I S
NEWS IN BRIEF
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EMA recommended 39 new drug approvals last year
The European Medicines Agency (EMA) recommended the approval of http://www.ema.europa.eu/docs/en_GB/document_library/Other/2016/01/WC500199664.pdf
Web End =39 new therapeutics in 2015, in line with 40 product recommendations in 2014 and up from 34 recommendations in 2013.
The EMAs approval cohort includes small molecules, antibodies, blood products and vaccines. The FDAs Center for Drug Evaluation and Research (CDER), which by contrast only oversees the approval of small molecules and certain types of biologics, approved 45 products in 2015.
The vast majority of the EMAs recommendations went to products that were approved by the FDA in either 2014 or 2015. As such, approval trends such as the high proportion of oncology and orphan product approvals are the same. For a detailed analysis of the FDAs 2015 approvals, see http://www.nature.com/nrd/journal/v15/n2/full/nrd.2016.15.html
Web End =Nat. Rev. Drug Discov. 15, 7376; 2016 .
The EMA did, however, recommend approval for three products that have not yet been approved by the FDA. The EMA recommended UCBs brivaracetam, a synaptic vesicle glycoprotein 2A (SV2A) ligand, for the treatment of epilepsy. The FDA was set to make a decision on the approval of brivaracetam in the United States as Nature Reviews Drug Discovery went to press. The EMA...