42 New Substances Among 84 EU Approval Recommendations In 2018
Executive SummaryThe EMA’s CHMP recommended EU marketing authorization for a total of 84 new drugs in 2018, containing a total of 42 new active substances. They included the EU’s first two CAR-T cell therapies, Kymriah and Yescarta, which were also among the 21 orphan medicines to gain a positive opinion from the committee.
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New approvals in the EU were again dominated by oncology drugs in 2018, although medicines for infectious diseases were a close second. The number of orphan drugs more than doubled over the previous year, to 17. There were also some star arrivals in multiple sclerosis, genetic disorders, metabolism and migraine.