In 2015, FDA experienced a banner year with respect to the number of novel drugs and biologics that were approved by the agency – 45 all told. Since then, the 21st Century Cures Act was passed with the goal, among other things, of facilitating the approval of new medicines. That piece of legislation is still in the process of implementation, but even so, it appears that FDA could be poised for another banner year of new approvals.
Comparing the first three quarters of the last three years, one can see that 2017 is on track to be an important year for approvals and if it keeps up at the current pace, could overtake 2015 in bringing new medicines out of the pipeline.
There are a lot of factors that go into this in terms of timing, and one of them is the way the NDA’s stack up. Looking at the last quarter of 2016 there were 12 breakthrough therapy requests submitted to FDA, more than any other quarter since inception of the program, and another 9 during the first two quarters. As breakthrough therapy status means FDA will expedite review of the drug candidate, this could be one of the factors in the increased number of approvals for this year.
And that also means that the approvals were not for “me-too” drugs either. As you can see below, the therapeutic categories for approvals were highly concentrated in cardio and oncology – two of the biggest causes of mortality as well as diseases of the central nervous system or mental health – Multiple Sclerosis, bipolar disorder and schizophrenia.
There still need to be eleven approvals during the last quarter to tie 2015. At the end of the fourth quarter, we’ll take another look at year end to see how we ended up. But the signs right now are pointing to not only a record year for approvals, one one in which the approvals are noteworthy and demonstrative of the policy drive the past few years to improve the process.