Table 1 Novel therapeutic agents and Associated Indications Approved by the U.S. Food and Drug Administration between 2011 and 2013
Number (%) | |
|---|---|
Novel therapeutics, n = 86 | |
Approval year | |
2011 | 27 (31.4 %) |
2012 | 35 (40.7 %) |
2013 | 24 (27.9 %) |
Number of approved indications | |
One | 80 (93.0 %) |
Two | 5 (5.8 %) |
Three | 1 (1.2 %) |
Associated indications, n = 92 | |
Therapeutic area | |
Cancer | 28 (30.4 %) |
Cardiovascular disease, diabetes mellitus, hyperlipidemia | 11 (12.0 %) |
Infectious disease | 9 (9.8 %) |
Autoimmune and musculoskeletal | 4 (4.3 %) |
Neurology | 7 (7.6 %) |
Dermatology | 5 (5.4 %) |
Psychiatry | 2 (2.2 %) |
Other | 26 (28.3 %) |
Orphan status | |
Yes | 30 (32.6 %) |
No | 62 (67.4 %) |
Number of pivotal trials | |
One | 41 (41.6 %) |
Two | 28 (30.4 %) |
Three | 11 (12.0 %) |
Four | 12 (13.0 %) |