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New Drug Review 2018

机译：2018年新药审查

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摘要

New molecular entities (NMEs), as defined by the FDA, are new drug products containing as their active ingredient a chemical substance marketed for the first time in the United States. The following descriptions of NMEs approved in 2017-2018 (table 1) detail the basic clinical and pharmacologic profiles of each new drug, as well as key precautions and warnings. Also included is a brief summary of selected pharmacokinetic, adverse-reaction, drug-interaction, and dosing data submitted to the FDA in support of the manufacturer's New Drug Application. This review is intended to be objective rather than evaluative in content.The information for each NME was obtained primarily from sources published prior to FDA approval. Experience clearly demonstrates that many aspects of a new drug's therapeutic profile are not detected in premarketing studies and emerge after the drug is used in large numbers of patients. Studies have demonstrated the appearance of "new" adverse reactions for many NMEs within several years after they first become available. Some of these drugs may eventually acquire at least one black box warning for serious adverse drug reactions or are withdrawn from the market for safety reasons that were not recognized at the time of approval. Therefore, while this review offers a starting point for learning about new drugs, it is essential that practitioners be aware of changes in a drug's therapeutic profile as reported in the pharmaceutical literature and by their own patients.
机译：由FDA定义的新分子实体（NMES）是新药物产品，其含有作为其活性成分的新药产品，这是美国首次销售的化学物质。以下描述2017 - 2018年批准的纽姆斯（表1）详细介绍了每种新药的基本临床和药物谱，以及关键的预防措施和警告。另外还包括一篇关于所选药代动力学，不利反应，药物相互作用和向FDA提交的给药数据的简要概述，以支持制造商的新药物应用。本综述旨在客观而不是内容的评估。每个NME的信息主要来自FDA批准之前发布的来源。经验清楚地证明，在预先售价研究中未检测到新药物治疗型材的许多方面，并且在大量患者使用药物后出现。研究表明，在首次可用后几年后，许多纽姆斯的“新”不良反应的外观。这些药物中的一些可能最终收购至少一个黑匣子警告，用于严重的不良药物反应，或者出于在批准时不承认的安全原因从市场上取出。因此，虽然这篇综述提供了一种了解新药的起点，但是从业者必须了解药物文学中报告的药物治疗型材的变化，并由其自己的患者提出。

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