美国FDA药物评价和研究中心（CDER）：2023年度新药获批报告（英文版）（33页）.pdf

1、CENTER FOR DRUG EVALUATION AND RESEARCHINNOVATION PREDICTABILITY ACCESSJanuary 2024Advancing Health Through Innovation:New Drug Therapy Approvals 2023 iiAdvancing Health Through Innovation:New Drug Therapy Approvals 2023Table of ContentsDirectors Message 1Executive Summary 2Innovation Across Medical

2、 Conditions 2New Drugs for Patients with Rare Diseases3Efficiencies in Bringing Therapies to Market 4CDERs Novel Drug Approvals of 2023 5First-in-Class Drugs 6Drugs for Rare Diseases 7Other Novel Drug Approvals 8Innovation:Use of Expedited Development and Review Pathways 10Fast Track 10Breakthrough

3、Therapy 11Priority Review11Accelerated Approval12Overall Use of Expedited Development and Review Methods 12Predictability:Meeting PDUFA Goals 13Access:First Cycle Approvals and First in US Approvals 14New Uses of Approved Drugs 16Approved Drugs Expanded for New Pediatric Populations 18Biosimilar App

4、rovals 20Conclusion 24Appendix A:CDERs Novel Approvals of 2023 25Appendix B:Novel Drug Designations 29 1Advancing Health Through Innovation:New Drug Therapy Approvals 2023Directors MessageWelcome to FDAs Center for Drug Evaluation and Researchs(CDER)13th annual report,Advancing Health Through Innova

5、tion:New Drug Therapy Approvals.This report highlights the role that CDER plays in bringing safe and effective drugs to patients and consumers.2023 was an important year for public health.Perhaps most notably,after more than three years,the U.S.Department of Health and Human Services declaration of

6、a Public Health Emergency(PHE)for COVID-19 ended in May.While the PHE has ended,CDER is con-tinuing to review drug applications for the treatment of COVID-19 infections.To that point,CDER approved the first oral antiviral pill for COVID-19 in 2023 and is supporting further drug development in this s