FDA 2015 Report on New Drug Approvals – A Banner Year

Greetings from the big blizzard of 2016.

With life in the slow lane for a bit, it was a good time to catch up on reading. One of those was a recently issued FDA report on the novel new drugs that were approved in 2015. It is a very thorough and well organized report and while it is worth summarizing a few things from it here, you are encouraged to download the original here. It was a banner year in approvals on a number of accounts.

First let’s just get perspective on how this year compares in terms of numbers to previous years from this chart provided by FDA in the report.

This year was not only unique because of the high number of approvals – 45 in all, but, as reported earlier, because so many of the new drug approvals involved oncology.

However it was also noteworthy that – but because of the large number of drugs approved had a special status attached to them. This was either because they were drugs to treat orphan conditions and/or because they were breakthrough, had accelerated approval, priority review or fast track status. In fact all in all, 60 percent of the approvals that occurred this year had some type of expedited status meaning FDA approved more drugs more quickly this year than in any previous year and nearly half were for rare conditions. Moreover FDA met the PDUFA date for approval 96 percent of the time and about two-thirds of the approvals were made here in the United States before being approved in any other country.

  • 45 New Novel Drugs in 2015
  • 16 (36 percent) were First-in-Class
  • 21 (45 percent) had Orphan status
  • 14 (31 percent) had Fast Track status
  • 10 (22 percent) had Breathrough status
  • 24 (53 percent) had Priority Review
  • 6 (13 percent) were under Accelerated Approval

Need the primer on the difference between all those expedited approval terms?  Click here.

The report has a lot more information and details of interest. In addition there is a very nice table that lists each approval with links to the original FDA press release where you can learn more. It certainly will be a tough year to top – let’s see.

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