CDER Report on Novel Approvals Highlights Firsts in 2017

Regulatory NewsRegulatory News | 10 January 2018 |  By 

2017 was a year of firsts for the US Food and Drug Administration’s (FDA) Center for Drug Evaluation and Research (CDER), with initial approvals in at least five medical conditions and other firsts that might not end up on the final scorecard, like the first biosimilar cancer treatment or the first immediate-release opioid with abuse-deterrent properties.

And though the total 46 approvals is the second-highest number of approvals by CDER ever, according to the CDER report released Wednesday, the numbers are not necessarily a good way to judge the agency, since it approves about 90% of all the applications it receives.

But for the FDA critics who complain that the agency is too slow or falling behind its foreign regulatory peers, CDER points to the fact that 100% of new drugs were approved within the timelines set by the user fee agreements, 61% were designated in one or more expedited categories of Fast Track, Breakthrough, Priority Review and/or Accelerated Approval, and 78% (36 of 46) were approved in the US before any other country.


Taking a step back and comparing these 2017 numbers with other previous years shows the agency has been relatively consistent across the board.

CDER identified 15 of the 46 novel drugs approved in 2017 (33%) as first-in-class, which is on par with 2016, when eight of 22 approved (36%) were considered first-in-class, and 2015, when CDER identified 16 of the 45 approved (36%) as first-in-class.

Similar to the first-in-class numbers, in 2017, 18 of CDER’s 46 novel drugs (39%) were approved to treat rare or “orphan” diseases that affect 200,000 or fewer Americans, whereas in 2016 that figure was nine of 22 novel drugs (41%) and in 2015, that figure was about 47%.

But 2017’s report differed from other previous years, as CDER discussed its approvals of drugs for new uses and new populations, as well as the five biosimilars approved in 2017, new formulations and new dosage forms.

And though the 2017 novel approval numbers do not include the approval of CAR-T therapies, Kymriah and Yescarta, in its total, the early stage venture capital blog Life Sci VC discussed the first-in-class approvals and other considerations.


CDER Director Janet Woodcock Blog Post

FDA Commissioner Scott Gottlieb Blog Post


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