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FDA Breakthrough Therapy Designation Statistics Chart

July 12, 2013





•   The CBER BTD #s are current as of 05/31/15 & the CDER BTD #s are current as of 05/29/15

•   The FDA updates the CBER BTD #s monthly & updates the CDER BTD #s every 2 weeks.


FDA CBER BTDs + CDER BTDs (as of 05/31/15) 

Breakthrough Therapy  Designation (BTD) Category Total # of CBER Designations (07/09/12-05/31/15) Total # of CDER Designations (07/09/12-05/29/15) Total # of CBER +   CDER BTD Designations (07/09/12-05/31/15)
Total # of BTD Requests Received 50 258 308
Total # of BTDs Granted 12 78 90
Total # of BTDs   Denied 37 132 169
Total # of BTDs   Pending 1 48 49


Seventy-one (71) BTDs have been identified by the sponsor companies as of June 4, 2015.  With 90 total BTDs granted, there are 19 that have not been identified by the sponsor company.

Per the FDA website:

“FDA will not disclose information regarding sponsors who submitted requests for or who have been granted or denied breakthrough therapy designation. Breakthrough therapy designation requests are typically submitted to an IND, and the FDA cannot disclose the existence of an IND, or any submissions that have been submitted to the IND, unless it has previously been publicly disclosed or acknowledged per 21 CFR 312.130(a).



FDA BTD Approval Chart

FDA BTD Statistics Chart.

Please Note: “Idea” PNG by Producer at ar.wikipedia (Transferred from ar.wikipedia) [Public domain] | Wikimedia Commons.

Copyright © 2012-2013, Orphan Druganaut Blog. All rights reserved.

  1. Anonymous permalink

    Should be 50 granted with 9 not disclosed per 5/16/14 FDA list.

  2. Anonymous permalink

    Where do you get 27 granted? The chart on the FDA website says 26.

    • Thanks for visiting the Blog.

      One of the Charts on the FDA website shows 26 CDER BTDs granted for the period of 10/01/12 – 09/06/13. Another chart on the FDA website shows 1 (CDER + CBER) BTDs granted for the period of 07/09/12 – 09/31/12. Thus, the FDA has granted 27 (CDER + CBER) BTDs for the time period of 07/09/12 (FDASTA signed) – 09/06/13.

      I hope that helps. Please let me know if you have any other questions.

      • Anonymous permalink

        Love the site. I do see that now. Thank you. Has there been any public discussion about the lengthy delay between the time the designation is granted and announced by companies? I can imagine the rules are still being written but I find it interesting the most recent Syndax breakthrough designation came with a comment from the CEO that the agency stated they would be receptive to using phase 2 data to support an application. Very promising for patients. Thanks again.

      • Thanks for your support for the Blog. It is greatly appreciated !!

        I have seen some articles over the past few months on the topic that you mentioned in your comment, about the delay between the time the Breakthrough Therapy Designation (BTD) is granted & when it is announced by the sponsor companies. I assume that each of the sponsor companies decide strategically when it is best to announce the BTD. I will take a look to see what information I can find on this interesting question.

        Yes, I agree with you that we should not lose sight that he BTDs is of great promise to all of the patients.

        Thanks again & have a great week !!

  3. M Souza permalink

    your site is a great resource. I know CBER is not that good on publishing the statistics, but you should have both CDER and CBER otherwise it paints an incomplete reality.

    • Thanks for visiting the Orphan Druganaut Blog. Your comments are greatly appreciaated in reference to including the CBER Breakthrough Therapy Designation #s with the CDER #s. We debated about this for awhile & based on this comment we agree with you that without CBER, the picture is not complete. Thanks again, Ann

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