The European Medicines Agency (EMA) recommended the approval of 39 new therapeutics in 2015, in line with 40 product recommendations in 2014 and up from 34 recommendations in 2013.
The EMA's approval cohort includes small molecules, antibodies, blood products and vaccines. The FDA's 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 EMA's 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 FDA's 2015 approvals, see Nat. Rev. Drug Discov. 15, 73–76; 2016.
The EMA did, however, recommend approval for three products that have not yet been approved by the FDA. The EMA recommended UCB's 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 recommended Grupo Ferrer's tiprolisant, an inverse histamine H3 receptor agonist, for the treatment of narcolepsy. And the EMA recommended Birken's Oleogel-S10, a betulin-rich birch bark extract, for wound healing.
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Mullard, A. EMA recommended 39 new drug approvals last year. Nat Rev Drug Discov 15, 77 (2016). https://doi.org/10.1038/nrd.2016.16
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DOI: https://doi.org/10.1038/nrd.2016.16
