Data analysis on new molecular entities approved by FDA in 2017
ZHANG Hua-ji
SUN Xiao-can
LIANG Yi
DING Li-xia
ZHU Feng-chang
Abstract：FDA approved a total of 46 novel new drugs, known as new molecular entities (NMEs) in2017, including 34 new drug applications (NDAs) and 12 new biological applications (BLAs). Approvals were up by over double from the 22 approved in 2016. The number of NMEs applications in 2017 with 48 applications was slightly higher than the previous years. 2017 was the year to date for first-in-class and orphan-drug approvals, with15 (32. 61％) first-in-class and 17 (36. 96％) orphan designees in the approval cohort. 17 NMEs had breakthrough-therapy designation. The current focus for drug R&D is on antineoplastic drugs, antimicrobial drugs, neurology drugs, metabolism and endocrinology drugs. About 1/3 of the 46 new drugs could become blockbuster drugs.
Keywords：innovative drugnew drug R&Dnew molecular entitynew drug approvalFDA
Publication Date：2018-01-01
Online Publishing Date：2026-08-14(First online date of this platform, not the publication date of the document)
Pages：5( 1697-1701 )