EU New Drug Approvals 2018: Anticancers, Orphans, The First CAR-Ts – And More
New drug approvals in the EU were again dominated by oncology in 2018, although medicines for infectious diseases came a close second. The number of orphan drugs more than doubled over the previous year, to 17. There were also some key new arrivals in the areas of multiple sclerosis, genetic disorders, metabolism and migraine.
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42 New Substances Among 84 EU Approval Recommendations In 2018
The 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.
New EU Approvals
Ten new products including Spark Therapeutics' gene therapy for treating patients with an inherited retinal disease, Luxturna, have been added to the Pink Sheet’s 2018 list of EU centralized approvals of new active substances. The list includes brand name, generic name, company, therapeutic category/indication, date of marketing authorization and product type (e.g., medicine, vaccine, biologic).
Luxturna's EU Approval Highlights Gene Therapy Pricing Challenges
Novartis/Spark Therapeutics’ transformative gene therapy Luxturna has just been approved in the EU. Like other gene therapies, it comes with a heavy price tag. So how will Novartis convince payers to pay, and how will payers cope with expensive, game changing therapies in the future?