Evaluate：2024年FDA获批：生物技术公司的主导作用研究报告（英文版）（14页）.pdf

1、Click here or press enter for the accessibility optimised versionBiotech SponsorsDominate 2024FDA ApprovalsBiotech sponsors accounted for almost twothirds of FDA approvals in 2024 a significantshift from the prior year,when big or mid-sizedpharma names sat behind just over half ofapprovals.Small mol

2、ecules also regained some of theground lost to biologics,accounting for 56%ofnew approvals,up from just half the prior year a sign that orally-available drugs still have theirplace despite the shorter exclusivity periodgranted to them in the 2021 Inflation ReductionAct.There were fewer surprises on

3、other counts.There were 61 approvals in total,of which wehave included 54*in this analysis(see note-right).These figures represent close to a ten-year average;a re-balancing,perhaps,after2023s exceptionally high count(71)-and 2022sunusual low(39).Cancer still dominates,with 17new drugs,including 6 o

4、f the 10 AcceleratedApprovals and three cell therapies.But auto-Introductionimmune,hematological,infectious andmetabolic/endocrine conditions each gained ahalf-dozen new therapies,there was a quartet ofCV approvals and 2024 also welcomed twoCNS newcomers,Bristol Myers SquibbsCobenfy for schizophreni

5、a and Eli Lillysdonanemab for Alzheimers disease.(See Chart 1&Table 1)The new Trump administration raises questionsfor 2025s FDA.Trumps nomination of Harvardphysician Marty Makary as FDA Commissionerwas less controversial than other nominations(such as Robert Kennedy Jr.as HHS Secretary).But the

6、 new US governments apparent urge todisrupt and streamline could impact FDAstaffing levels and/or approval timelines.CDERdirector Patrizia Cavazzoni announced herresignation in early January 2025,following thatof deputy head Namandj Bumpus inDecember.Chart 1:FDAs 2024approvals by therapy areaSource: