TY - JOUR
T1 - 2019 in review
T2 - FDA approvals of new medicines
AU - Kinch, Michael S.
AU - Kraft, Zachary
AU - Schwartz, Tyler
N1 - Funding Information:
Research reported in this publication was solely supported by Washington University in St Louis.
Publisher Copyright:
© 2020 Elsevier Ltd
PY - 2020/11
Y1 - 2020/11
N2 - The US Food and Drug Administration (FDA) green-lighted the marketing of 53 therapeutic agents in 2019. This rate of approvals was consistent with the 5-year running average. Nonetheless, a few changes are worth noting. The rate of medicines first approved using an orphan drug designation declined from 56% in 2018 to 41% in 2019, which mirrored a comparable decline in the use of priority review. A second notable feature was an uptick in industry consolidation. Twenty-five companies were lost, primarily because of mergers, leaving only 146 extant companies that have contributed to the research or development of an innovative FDA-approved medicine.
AB - The US Food and Drug Administration (FDA) green-lighted the marketing of 53 therapeutic agents in 2019. This rate of approvals was consistent with the 5-year running average. Nonetheless, a few changes are worth noting. The rate of medicines first approved using an orphan drug designation declined from 56% in 2018 to 41% in 2019, which mirrored a comparable decline in the use of priority review. A second notable feature was an uptick in industry consolidation. Twenty-five companies were lost, primarily because of mergers, leaving only 146 extant companies that have contributed to the research or development of an innovative FDA-approved medicine.
UR - http://www.scopus.com/inward/record.url?scp=85091604292&partnerID=8YFLogxK
U2 - 10.1016/j.drudis.2020.09.002
DO - 10.1016/j.drudis.2020.09.002
M3 - Short survey
C2 - 32927064
AN - SCOPUS:85091604292
SN - 1359-6446
VL - 25
SP - 1923
EP - 1929
JO - Drug Discovery Today
JF - Drug Discovery Today
IS - 11
ER -