{"title":"Sipavibart: First Approval.","authors":"Susan J Keam","doi":"10.1007/s40265-025-02186-w","DOIUrl":null,"url":null,"abstract":"<p><p>Sipavibart (KAVIGALE<sup>®</sup>), a recombinant human immunoglobulin (Ig)G1-based antibody, is being developed by AstraZeneca for the pre-exposure prophylaxis of COVID-19 in immunocompromised individuals. Sipavibart was approved in December 2024 in Japan to prevent the onset of infection caused by SARS-CoV-2 in adults and adolescents aged ≥ 12 years weighing ≥ 40 kg where vaccination against infection caused by SARS-CoV-2 is not recommended or may not achieve a sufficient immune response. Sipavibart was also approved in the EU for the pre-exposure prophylaxis of COVID-19 in adults and adolescents aged ≥ 12 years weighing ≥ 40 kg who are immunocompromised due to a medical condition or receipt of immunosuppressive treatments in January 2025 and in Canada in March 2025. This article summarizes the milestones in the development of sipavibart leading to this first approval for the pre-exposure prophylaxis of COVID-19 in immunocompromised adults and adolescents.</p>","PeriodicalId":11482,"journal":{"name":"Drugs","volume":" ","pages":""},"PeriodicalIF":13.0000,"publicationDate":"2025-06-09","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":null,"platform":"Semanticscholar","paperid":null,"PeriodicalName":"Drugs","FirstCategoryId":"3","ListUrlMain":"https://doi.org/10.1007/s40265-025-02186-w","RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q1","JCRName":"PHARMACOLOGY & PHARMACY","Score":null,"Total":0}
引用次数: 0
Abstract
Sipavibart (KAVIGALE®), a recombinant human immunoglobulin (Ig)G1-based antibody, is being developed by AstraZeneca for the pre-exposure prophylaxis of COVID-19 in immunocompromised individuals. Sipavibart was approved in December 2024 in Japan to prevent the onset of infection caused by SARS-CoV-2 in adults and adolescents aged ≥ 12 years weighing ≥ 40 kg where vaccination against infection caused by SARS-CoV-2 is not recommended or may not achieve a sufficient immune response. Sipavibart was also approved in the EU for the pre-exposure prophylaxis of COVID-19 in adults and adolescents aged ≥ 12 years weighing ≥ 40 kg who are immunocompromised due to a medical condition or receipt of immunosuppressive treatments in January 2025 and in Canada in March 2025. This article summarizes the milestones in the development of sipavibart leading to this first approval for the pre-exposure prophylaxis of COVID-19 in immunocompromised adults and adolescents.
期刊介绍：
Drugs is a journal that aims to enhance pharmacotherapy by publishing review and original research articles on key aspects of clinical pharmacology and therapeutics. The journal includes:
Leading/current opinion articles providing an overview of contentious or emerging issues.
Definitive reviews of drugs and drug classes, and their place in disease management.
Therapy in Practice articles including recommendations for specific clinical situations.
High-quality, well designed, original clinical research.
Adis Drug Evaluations reviewing the properties and place in therapy of both newer and established drugs.
AdisInsight Reports summarising development at first global approval.
Moreover, the journal offers additional digital features such as animated abstracts, video abstracts, instructional videos, and podcasts to increase visibility and educational value. Plain language summaries accompany articles to assist readers with some knowledge of the field in understanding important medical advances.
求助内容：
应助结果提醒方式：
京公网安备 11010802042870号
