Table 1. Characteristics of Supplemental New Indication Drugs and Biologics Approved by the US FDA for New Indications from 2017 to 2019, and the New Drugs and Biologics Approved by the FDA for the Corresponding Original Indications.
| Characteristic | Approvals, No. (%) | |
|---|---|---|
| Supplemental new indication (n = 146)a | Original (n = 109) | |
| Approval year | ||
| Before 2010 | NA | 23 (21) |
| 2010-2014 | NA | 45 (41) |
| 2015-2019 | 146 (100) | 41 (38) |
| Agent type | ||
| Pharmacologics | 99 (68) | 69 (63) |
| Biologics | 47 (32) | 40 (37) |
| Special regulatory program | ||
| Any | 74 (51) | 57 (52) |
| Accelerated approval | 20 (14) | 25 (23) |
| Priority review | 61 (42) | 55 (50) |
| Fast track | NA | 10 (9) |
| Breakthrough | 35 (24) | 17 (16) |
| Therapeutic area | ||
| Autoimmune or musculoskeletal | 24 (16) | 5 (5) |
| Infectious diseases | 5 (3) | 6 (6) |
| Neurology | 8 (5) | NAb |
| Dermatology | NAb | 7 (6) |
| Cardiovascular, diabetes, and lipids | 9 (6) | 13 (12) |
| Cancer | 78 (53) | 46 (42) |
| Other | 22 (15) | 7 (6) |
Abbreviations: FDA, US Food and Drug Administration; NA, not applicable.
a
Supplemental approvals are not eligible for Fast Track designation.
b
Therapeutic areas with fewer than 5 new indications or original indication approvals, respectively, are consolidated into the other category.