The FDA approved 59 investigational drugs to be released to distribution in 2018, beating the 2017 total of 46. The number of approvals in 2018 also sets a record for the number of new drug approvals in a single year. The previous highest annual total was 53 in 1996.
Almost 3/4 of the drugs (43) had priority reviews. Almost half of the priority reviews were filed as orphan drugs (34), while 58% were for rare diseases, 41% had Fast Track status and almost a quarter were designated as Breakthrough Therapies (14). Through its work in streamlining and optimizing drug reviews, 71% of drugs were first approved in the U.S. All drugs were approved by or before their PDUFA dates.
The FDA was not the only one that increased the number of new drugs approved in 2018. The European Medicine Agency approved 42 new drugs last year, which is up from 35 in 2017. This included 21 drugs that were designated Orphan Drugs. As in the U.S., the largest therapeutic group were the 23 oncology drugs approved.
Congress passed Right-To-Try legislation in the spring of 2018. Formal guidelines have not been announced, but ERC-1671 (Gliovacfrom Epitopoietic Research Corp)became the first right to try drug in the fall.
Notable approvals in 2018
A total of 14 infectious disease drugs that included:
Medscape's Review of New Drug Approvals
The FDA's 2018 Drug Therapy Approvals
The FDA's List of 2018 Drug Approvals by Medical Specialty
PM Live's Review of European 2018 Drug Approvals
Specialty Pharmacy Time's Review of Top Ten Specialty Pharmaceutical Approvals
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