资讯详情
返回资讯目录2013年12月11日，美国FDA科学中心副主任Richard Moscicki发布了一份今年新药审批工作的初步成绩单，自我评价积极。这位副主任说：2013年到目前为止，他们的部门已批准了26个新分子实体（NME）。虽然也有称是25个，这是因为吉列德科学公司的丙型肝炎新药Solvadi（sofosbuvir）批准时间较晚，未来得及被制作在讲演稿内。
虽然专利悬崖问题继续对制药工业造成伤害，市场研究公司EvaluatePharma所作的一份2013年11月评估显示今年获准新药数量相对较少，不应该认为是将投资者推向边缘。其理由是：获准药品的价值明显提高，预期它们获准后5年内在美国销售额为187亿美元，远远超过2012年获准新药获准后5年在美国的预期市场价值139亿美元。
2013年FDA批准的新药中有90%在一个审查周期完成，另外几乎有75％是世界范围首次获准的。
罕用药获准比例相对稳定，约占36％，今年有3个突破性新药获准，它们是： 丙型肝炎药Solvadi，以及2个抗癌药，即强生的Imbruvica（ibrutinib）和罗氏的Gazyva（obinutuzumab）。
强生盛赞FDA的“突破性新药”新政的作用和影响力。不过FDA的统计数据表明，该机构对突破性新药的认定并不慷慨，申请认定的获准率只有30%。
(The Drug Name link provides full product details, i.e., prescribing information, approval history, and reviews.)
Innovation drives progress. When it comes to innovation in the development of new drugs and therapeutic biological products, FDA’s Center for Drug Evaluation and Research (CDER) supports the pharmaceutical industry at every step of the process. With its understanding of the science used to create new products, testing and manufacturing procedures, and the diseases and conditions that new products are designed to treat, FDA provides scientific and regulatory advice needed to bring new therapies to market. The availability of new drugs and biological products often means new treatment options for patients and advances in health care for the American public. For this reason, CDER supports innovation and plays a key role in helping to advance new drug development.
Each year, CDER approves a wide range of new drugs and biological products. Some of these products are innovative new products that never before have been used in clinical practice. Others are the same as, or related to, previously approved products, and they will compete with those products in the marketplace.
| Certain drugs are classified as new molecular entities (“NMEs”) for purposes of FDA review. Many of theseproducts contain active moieties that have not been approved by FDA previously, either as a single ingredient drug or as part of a combination product; these products frequently provide important new therapies for patients. Some drugs are characterized as NMEs for administrative purposes, but nonetheless contain active moieties that are closely related to active moieties in products that have previously been approved by FDA. For example, CDER classifies biological products submitted in an application under section 351(a) of the Public Health Service Act as NMEs for purposes of FDA review, regardless of whether the Agency previously has approved a related active moiety in a different product. FDA’s classification of a drug as an “NME” for review purposes is distinct from FDA’s determination of whether a drug product is a “new chemical entity” or “NCE” within the meaning of the Federal Food, Drug, and Cosmetic Act. |
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