CDER Approvals Shot Up 28% in 2018: Report

CDER saw a 28% increase in novel new drug approvals last year — jumping from 46 approvals in 2017 to 59 in 2018. In contrast, over the past ten years CDER has averaged about 33 novel drug approvals per year, according to a just-released report.

A close look at the report shows that 34 novel approvals were for treating rare diseases, and 19 were identified as first-in-class. “These drugs often have mechanisms of action different from those of existing therapies,” the report says.

FDA says that 24 approvals benefited under its fast track program. This “speeds new drug development and review by increasing the level of communication between FDA and drug developers, and by enabling CDER to review portions of a drug application ahead of the submission of the complete application,” it says.

CDER also designated 14 of the 59 novel drugs in 2018 as breakthrough therapies. A breakthrough therapy designation includes all the fast track program features, as well as more intensive FDA guidance on an efficient drug development program. “Breakthrough therapy designation is designed to help shorten the development time of a potential new therapy,” the report says.

In rating CDER’s review performance, the report notes that the Center met or exceeded every user fee goal date for application reviews. CDER approved 56 of the 59 novel drugs of 2018 (95%) on the “first cycle” of review and without issuing a complete response letter requesting additional data or information. “From 2011 through 2017, CDER approved 250 novel drugs, of which 205 (82%) were approved on the first cycle,” the report says.