Table 1.
Characteristics of 343 new therapeutics receiving original Food and Drug Administration approval, 2009–2018.
| Therapeutic characteristic | Number of therapeutics | No. (%) | P values | |
|---|---|---|---|---|
| No clinical PMRs or PMCs at approvala | At least one clinical PMR or PMC at approval | |||
| Total | 343 | 71 | 272 | - |
| Year of approval | ||||
| 2009 | 26 (7.6) | 5 (7.0) | 21 (7.7) | .99 |
| 2010 | 21 (6.1) | 4 (5.6) | 17 (6.3) | |
| 2011 | 28 (8.2) | 6 (8.5) | 22 (8.1) | |
| 2012 | 36 (10.5) | 8 (11.3) | 28 (10.3) | |
| 2013 | 24 (7.0) | 6 (8.5) | 18 (6.6) | |
| 2014 | 39 (11.4) | 9 (12.7) | 30 (11.0) | |
| 2015 | 45 (13.1) | 8 (11.3) | 37 (13.6) | |
| 2016 | 20 (5.8) | 3 (4.2) | 17 (6.3) | |
| 2017 | 45 (13.1) | 11 (15.5) | 34 (12.5) | |
| 2018 | 59 (17.2) | 11 (15.5) | 48 (17.6) | |
| Class | ||||
| Drug | 258 (75.2) | 59 (83.1) | 199 (73.2) | .09 |
| Biologic | 85 (24.8) | 12 (16.9) | 73 (26.8) | |
| Therapeutic area | ||||
| Autoimmune, musculoskeletal, and dermatology | 39 (11.4) | 6 (8.5) | 33 (12.1) | < .001 |
| Cancer and hematology | 97 (28.3) | 16 (22.5) | 81 (29.8) | |
| Cardiovascular and diabetes | 40 (11.7) | 10 (14.1) | 30 (11.0) | |
| Gastrointestinal and metabolism | 31 (9.0) | 3 (4.2) | 28 (10.3) | |
| Infectious disease | 55 (16.0) | 5 (7.0) | 50 (18.4) | |
| Neurology and psychiatry | 34 (9.9) | 7 (9.9) | 27 (9.9) | |
| Other | 47 (13.7) | 24 (33.8) | 23 (8.5) | |
| Priority review | ||||
| Yes | 185 (53.9) | 33 (46.5) | 152 (55.9) | .18 |
| No | 158 (46.1) | 38 (53.5) | 120 (44.1) | |
| Fast track | ||||
| Yes | 134 (39.1) | 26 (36.6) | 108 (39.7) | .68 |
| No | 209 (60.9) | 45 (63.4) | 164 (60.3) | |
| Accelerated approval | ||||
| Yes | 41 (12.0) | 0 (0) | 41 (15.1) | < .001 |
| No | 302 (88.0) | 71 (100.0) | 231 (84.9) | |
| Breakthrough therapy | ||||
| Yes | 59 (17.2) | 10 (14.1) | 49 (18.0) | .49 |
| Nob | 284 (82.8) | 61 (85.9) | 223 (82.0) | |
| Orphan drug designation | ||||
| Yes | 142 (41.4) | 33 (46.5) | 109 (40.1) | .35 |
| No | 201 (58.6) | 38 (53.5) | 163 (59.9) | |
PMRs: postmarketing requirements; PMCs: postmarketing commitments.
a
Includes therapeutics approved with no postmarketing requirements or commitments and therapeutics approved with non-clinical postmarketing requirements and/or commitments only.
b
Includes 88 (25.7%) therapeutics approved prior to origination of the Breakthrough Therapy designation on 9 July 2012.