FDA | 2017年批准的新药（Novel Drug Approvals for 2017）

原文始发于微信公众号（药时代）：FDA | 2017年批准的新药（Novel Drug Approvals for 2017）

23个新药获得FDA批准！

23个新药由22家公司平分！

群雄逐鹿，百舸争流！

诺华是唯一一家获得2项批准的公司！

药时代热烈祝贺22家公司！

1. PORTOLA PHARMA INC

2. MELINTA THERAPEUTICS INC

3. SANOFI SYNTHELABO

4. MITSUBISHI TANABE

5. ASTRAZENECA UK LTD

6. RADIUS HEALTH INC

7. NOVARTIS PHARMS CORP

8. ARIAD

9. BIOMARIN PHARM

10. NEUROCRINE

11. TEVA BRANDED PHARM

12. GENENTECH INC

13. REGENERON PHARMACEUTICALS

14. TESARO INC

15. SHIONOGI INC

16. EMD SERONO INC

17. US WORLDMEDS LLC

18. NOVARTIS PHARMS CORP

19. LEXICON PHARMS INC

20. VALEANT LUXEMBOURG

21. PTC THERAPEUTICS

22. KAI PHARMS INC

23. SYNERGY PHARMS

创新推动进步。在开发新药和治疗性生物制品方面，FDA的药物评估与研究中心（CDER）在漫漫研发征途中的每一步都倾力支持制药行业。基于对新产品的创造、测试和制造等流程背后的科学以及新产品针对的疾病和状况的理解，FDA、CDER提供了将新疗法推向市场所需的科学建议和法规咨询。

新药物和生物制品的可及性通常意味着患者获得新的治疗方案和美国公众受益于医疗保健进展。因此，CDER支持创新，并在推动新药开发方面发挥关键作用。

每年，CDER都批准一大批新药和生物制品，涉及的范围广泛。其中一些产品是从未在临床实践中使用的创新型新产品。其它的与以前批准的产品相同或相关，它们将与市场上的这些产品竞争从而降低药价，让患者最终获益。

2017年，截止2017年6月23日，FDA共批准了23个新药。点击可欣赏大图！

中文版本

英文版本

出于FDA审评的考量，一部分药物被列为新分子实体（New Molecular Entities ，NME）。许多这些产品含有未经FDA批准的活性部分，作为单一成分药物或作为组合产品的一部分；这些产品经常为患者提供重要的新疗法。另外一些药物被表征为NME是出于管理目的，但仍然包含与以前被FDA批准的产品中的活性部分密切相关的活性部分。例如，便于FDA审评，CDER将根据公共卫生服务法第351（a）节申请提交的生物制品归类为NME，无论FDA以前是否批准了不同产品中的相关活性部分。FDA出于审评目的将药物分类为“NME”不同于FDA基于“联邦食品、药品和化妆品法”的“新化学实体”（new chemical entity，NCE）的定义而做出的决定。

Novel Drug Approvals for 2017

Last Updated: 06/23/2017

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 these products 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.

For see above for the table.

*This information is currently accurate. In rare instances, it may be necessary for FDA to change a drug’s new molecular entity (NME) designation or the status of its application as a novel new biologics license application (BLA). For instance, new information may become available which could lead to a reconsideration of the original designation or status. If changes must be made to a drug’s designation or the status of an application as a novel BLA, the Agency intends to communicate the nature of, and the reason for, any revisions as appropriate.

(Source: FDA website)

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