Northwestern Medicine, Chicago, IL, USA.
IPD Analytics, Aventura, FL, USA.
Am J Health Syst Pharm. 2024 Nov 7;81(22):1103-1108. doi: 10.1093/ajhp/zxae242.
Health-system pharmacists play a crucial role in monitoring the pharmaceutical pipeline to manage formularies, allocate resources, and optimize clinical programs for new therapies. This article aims to support pharmacists by sharing new and anticipated novel drug approvals.
Selected drug approvals anticipated in the 12-month period covering the third quarter of 2024 through the second quarter of 2025 are reviewed. The analysis emphasizes drugs expected to have significant clinical and financial impact in hospitals and clinics selected from 54 novel drugs awaiting US Food and Drug Administration approval. New cell therapies for treating cancers continue to enter the drug pipeline, while novel targeted therapies for biliary tract, gastric, pancreatic, and breast cancers, as well as 3 subcutaneous versions of already approved drugs given intravenously, are awaiting approval. Additionally, many novel drugs are being developed for treatment of rare and ultra-rare diseases such as hereditary angioedema, macular telangiectasia, congenital adrenal hyperplasia, and Barth syndrome. Two new subcutaneous drugs for hemophilia, a new oral medication for hereditary angioedema, a novel monoclonal antibody for atopic dermatitis, and the first oral penem antibiotic are also in the pipeline.
New drugs with various indications for cancers and rare diseases continue to strengthen the drug pipeline.
医疗体系药剂师在监控药物研发管道以管理处方、分配资源和优化新疗法的临床方案方面发挥着关键作用。本文旨在通过分享新的和预期的新型药物批准来支持药剂师。
审查了预计在 2024 年第三季度至 2025 年第二季度的 12 个月内获得批准的选定药物。该分析重点介绍了从等待美国食品和药物管理局批准的 54 种新型药物中选择的预计在医院和诊所具有重要临床和经济影响的药物。用于治疗癌症的新型细胞疗法继续进入药物研发管道，而用于胆管癌、胃癌、胰腺癌和乳腺癌的新型靶向疗法，以及已批准的 3 种静脉内皮下版本药物，正在等待批准。此外，许多新型药物正在开发用于治疗遗传性血管性水肿、黄斑毛细血管扩张症、先天性肾上腺增生症和巴思综合征等罕见和超罕见疾病。还有两种用于血友病的新型皮下药物、一种用于遗传性血管性水肿的新型口服药物、一种用于特应性皮炎的新型单克隆抗体，以及第一种口服青霉素类抗生素也在研发管道中。
针对癌症和罕见疾病的各种适应症的新药继续加强药物研发管道。
