FDA2024年新药审评报告--Bydrug医药资源云

Advancing Health Through Innovation: New Drug Therapy Approvals 2024CENTER FOR DRUG EVALUATION AND RESEARCHINNOVATION | PREDICTABILITY | ACCESSJanuary 2025Table of ContentsDirector’s Message ......................................................1Executive Summary ................................................... 2Innovation Across Medical Conditions .....................................................................2New Drugs for Patients with Rare Diseases.............................................................3Efficiencies in Bringing Therapies to Market ............................................................4CDER’s Novel Drug Approvals of 2024 .......................... 5First-in-Class Drugs ..................................................................................................6Drugs for Rare Diseases ..........................................................................................7Other Novel Drug Approvals ....................................................................................9Innovation: Use of Expedited Development and Review Pathways ............................ 11Fast Track ............................................................................................................... 11Breakthrough Therapy ............................................................................................12Priority Review........................................................................................................12Accelerated Approval..............................................................................................12Overall Use of Expedited Development and Review Methods ...............................13Predictability: Meeting PDUFA Goals ...........................14Access: First Cycle Approvals and First in U.S. Approvals .........................................15New Uses of Approved Drugs ......................................17Approved Drugs Expanded for New Pediatric Populations ....................................19Biosimilar Approvals .................................................21Other Important Approvals ........................................23Conclusion ............................................................... 25Appendix A: CDER’s Novel Approvals ............................26Appendix B: Novel Drug Designations ...........................30 iiAdvancing Health Through Innovation: New Drug Therapy Approvals 2024Director’s MessageWelcome to FDA’s Center for Drug Evaluation and Research’s (CDER) 14th annual report, Advancing Health Through Innovation: New Drug Therapy Approvals. The 2024 New Drug Therapy Approvals report is designed to showcase CDER’s role in bringing safe and effective drugs to market for patients and consumers.This report describes CDER’s 2024 notable drug approvals, which are actions we consider likely to have a significant impact on patient care and public health. These include novel drug approvals that contain a new active i