Marstacimab：首次批准。

IF 13 1区医学 Q1 PHARMACOLOGY & PHARMACY

Drugs Pub Date : 2024-12-24 DOI:10.1007/s40265-024-02130-4

Yvette N Lamb

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引用次数: 0

摘要

Marstacimab (marstacimab-hncq;HYMPAVZI™是一种皮下给药的抗组织因子通路抑制剂（TFPI）的人单克隆免疫球蛋白G1抗体，由辉瑞公司开发，用于治疗a和b型血友病。该药被批准用于成人和12岁及以上血友病A（不含因子VIII抑制剂）或血友病B（不含因子IX抑制剂）患者的常规预防，以预防或减少出血发作频率。此后，Marstacimab于11月18日在欧盟被批准用于治疗成人和青少年严重血友病A或B的无抑制剂治疗。本文总结了marstacimab首次获批用于血友病的发展里程碑。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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Marstacimab: First Approval.

Marstacimab (marstacimab-hncq; HYMPAVZI™) is a subcutaneously administered human monoclonal immunoglobulin G1 antibody against tissue factor pathway inhibitor (TFPI) that is being developed by Pfizer for the treatment of hemophilia A and B. Marstacimab received its first approval on 11 October 2024 in the USA. It was approved for use as routine prophylaxis to prevent or reduce the frequency of bleeding episodes in adult and pediatric patients 12 years of age and older with hemophilia A without factor VIII inhibitors or hemophilia B without factor IX inhibitors. Marstacimab has since been approved on 18 Nov in the EU for the treatment of adults and adolescents with severe hemophilia A or B without inhibitors. This article summarizes the milestones in the development of marstacimab leading to this first approval for hemophilia.

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来源期刊

Drugs 医学-毒理学

CiteScore

22.70

自引率

0.90%

发文量

134

审稿时长

3-8 weeks

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.