首页 > 资讯 > 2015：FDA新药批准的又一强劲年

出自识林

2016-01-05 FDA Voice

（摘自FDA Voice “2015: Another Strong Year for Patients in Need of New Drug Therapies” 2016年1月4日，作者：John Jenkins，医师，FDA药品审评与研究中心新药办公室主任）

回首2015，我很高兴向大家报告又一个FDA新药批准的强劲一年，为许多患者的严重和危及生命的疾病提供了新的治疗选择。2015年，FDA药品审评和研究中心（CDER）批准共批准45个新药，显著超越过去9年间每年批准28个新药的平均量。

质量远比数量更重要 – 其中许多药物在推进医疗保健和患者健康方面扮演着重要的新角色。在过去一年里，我们批准了许多新药用于治疗各种癌症，包括4个用于治疗多发性骨髓瘤的新药，和其它用于治疗肺癌、皮肤癌、乳腺癌、脑癌、肠癌等多种癌症的新药。我们还批准了用于治疗心脏衰竭、高胆固醇、囊性纤维化和肠易激综合征的药品，以及首个获批对于常用血液稀释剂的逆转剂。连续第二年，与历史上以往任何一年相比，我们批准了更多用于治疗罕见疾病的药品。

以下是这些批准的几大亮点：

• 2015年CDER批准的新药中超过三分之一被FDA认定为“同类药品中首次获批（first-in-class）”，例如，使用新的和独特的作用机制用于治疗疾病的药品；

• 超过40%的新药获批用于治疗影响20万或更少美国人的罕见或“孤儿”疾病，这些罕见病患者通常只有很少的治疗用药或无药可治；

• 2015年CDER批准的新药中60%被认定为快速通道、突破性治疗、优先审评或加速审批中的一个或多个类别。所有这些认定都有助于加快研发和/或批准流程，旨在帮助重要药品尽快推向市场；

• CDER批准的新药中64%在美国率先批准。

有关2015年批准的更多详情，请访问2015年新药总结。

一如既往，在我们尽可能高效的评估申请时，我们在审评标准方面并没有妥协。总之，这些药品在获批之前均已证明其安全性和有效性。我为作为促成这些新药尽可能安全地进入市场的团队的一部分而感到高兴和自豪。我的同事和我期待另一个服务于美国公众的丰收年！

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2015: Another Strong Year for Patients in Need of New Drug Therapies
Posted on January 4, 2016 by FDA Voice
By: John K. Jenkins, M.D.

Happy New Year! Looking back at 2015, I’m pleased to report another strong year for FDA approvals of novel new drugs, which offer many patients new treatment options for serious and life-threatening conditions. In 2015, FDA’s Center for Drug Evaluation and Research (CDER) approved 45 novel new therapies – significantly more than the average of 28 we have approved during the previous nine years of this decade.

John JenkinsBut far more important than quantity is quality – and the valuable new roles many of these drugs can serve in advancing medical care and the health of patients. During this past year, we approved many new drugs to treat various forms of cancer, including four to treat multiple myeloma, and others to treat lung, skin, breast, brain, colorectal, and other cancers. We also approved new drugs to treat heart failure, high cholesterol, cystic fibrosis, and irritable bowel syndrome, as well as the first approved reversal agent for a commonly-used blood thinner. And, for the second consecutive year, we approved more drugs to treat rare diseases than any previous year in our history.

Here are a few highlights of these approvals:

• More than one-third of the novel new drugs CDER approved in 2015 were identified by FDA as “first-in-class,” for example, drugs that use a new and unique mechanism of action for treating a medical condition;
• More than 40% of these new therapies were approved to treat rare or “orphan” diseases that affect 200,000 or fewer Americans–Americans who often have few or no drug treatment options;
• 60% of CDER’s novel new approvals for 2015 were designated in one or more categories of Fast Track, Breakthrough, Priority Review, or Accelerated Approval. Each of these designations helps speed the development and/or approval process and is designed to help bring important medications to the market as quickly as possible; and
• 64% of CDER’s novel new approvals were approved first in the United States before any other country.

For more details about 2015's approvals, please visit the Novel New Drugs Summary 2015.

As always, compromises were not made in our review standards as we considered the applications as efficiently as possible. In short, each of these therapies had to demonstrate that it was safe and effective before being approved. I am pleased and proud to be part of a team that helped bring these new drugs to market as safely as possible. My colleagues and I look forward to another productive year serving the American public!