The Year That Was: Novel Drug Approvals Of 2016

(RTTNews) - Another busy and challenging year for the FDA is coming to a close. Only 21 novel new drugs have been so far approved in 2016, and that pales in comparison with last year's 45 approved drugs. The number of novel drug approvals from 2005 through 2014 averaged nearly 27 per year.

Novel drugs are new molecular entities (NMEs) having chemical structures that have never been approved before.

Of the 21 new molecular entities approved this year, 8 have been granted orphan drug status and 7 have been designated as Breakthrough therapy. Last year, 21 of the 45 novel drugs approved were tagged Orphan drugs while 10 were granted Breakthrough therapy status.

According to the Office of New Drugs Director John Jenkins, the sharp drop-off in the number of new molecular entities approved in 2016 is due to the following reasons:

- Five NMEs with decision dates due in 2016 were approved in 2015 itself, ahead of schedule.

- The number of regulatory filings (NDA/BLA) by the pharma companies this year was comparatively less than 2015.

- The number of Complete response Letters issued by the FDA in 2016 is more compared to last year.

This article presents a re-cap of the drugs that cleared the FDA regulatory hurdles and got across the finish line in 2016.