FDA Breakthrough Therapy Designation: Impact Report From Tufts

January 28, 2014

Tufts Center for the Study of Drug Development (CSDD) is an independent academic non-profit research group at Tufts University in Boston, Massachusetts. The mission of the Tufts CSDD :

“ is to develop strategic information to help drug developers, regulators, and policy makers improve the quality and efficiency of pharmaceutical and biopharmaceutical development, review, and utilization.”

One of Tufts CSDD products is the bi-monthly Impact Reports, that summarize current original research from the organization in an easy compact format. This series of reports analyzes data and provides information on current drug regulatory and development issues.

The latest Impact Issue is the January/February 2014 issue titled, “New Breakthrough Therapy Designation (BTD) program aims to cut clinical trial time”. The Summary Report is available for FREE. According to the Press Release, of the first 113 BTD requests received (between July 9, 2012 – December 17, 2013) by the FDA :

• 30 % are approved

• 60 % are denied/withdrawn

• 10 % are pending.

According to the most recent Orphan Druganaut Blog Post, of the 144 BTD requests (CBER + CDER) received by the FDA for the period July 9, 2012 – January 22, 2014):

• 25.7 % are approved

• 53.5 % are denied

• 20.8 % are pending.

Please keep in mind that the Blog’s figures are based on a different date range, the CBER numbers are current as of 12/31/13, and the CDER numbers are current as of 01/22/14.

Other observations from the Tufts CSDD January/February Summary Impact Report:

• Central nervous systems drugs and diagnostics are likely to be significant beneficiaries of the BTD program

• Orphan and oncology drugs dominated the first class of BTDs awarded by the FDA.

References

Online article, “Breakthrough Therapy Designation: Faster cancer drug approval ?”

FDA BTD: 2013 In Review

FDA BTD Chart

FDA BTD Approval Chart

FDA BTD Statistics Chart.

Please Note: “IMG Carlingford Lough 0617” by By Sarah777 at en.wikipedia [Public domain] | Wikimedia Commons.