US FDA novel new drug approvals in 2015 hit a 19-year record high of 45

In calendar year 2015, the US Food and Drug Administration’s Center for Drug Evaluation and Research (CDER) approved 45 novel new drugs, approved as new molecular entities (NMEs) under New Drug Applications or as new therapeutic biologics under Biologics License Applications.

This compares with 41 in 2014, 27 in 2013, 39 in 2012, and is the highest number for 19 years. Many of the 45 novel new drugs the CDER approved in 2015 are notable for their potential positive impact and unique contributions to quality medical care and public health. 64% of the CDER’s novel new approvals were approved first in the USA before any other country.

The CDER identified 16 of the 45 novel new drugs approved in 2015 (36%) as first-in-class, one indicator of the innovative nature of a drug. These drugs often have mechanisms of action different from those of existing therapies. This first-in-class approval rate is one factor that suggests the 2015 group of novel new approvals is a field comprised of many innovative products.