Table. Characteristics of Drug Indications Granted Accelerated Approval and Conditional Marketing Authorization by the FDA and EMA.
| Therapeutic area | Drug indications, No. (%) | |||
|---|---|---|---|---|
| Accelerated approval | Conditional marketing authorization | Available therapeutic value rating | ||
| FDA | EMA | |||
| All | 146 (100) | 58 (100) | 90 (100) | 56 (100) |
| Antineoplastic | 122 (83.6) | 40 (69.0) | 75 (83.3) | 39 (69.6) |
| Anti-infective | 9 (6.2) | 8 (13.8) | 8 (8.9) | 7 (12.5) |
| Blood and cardiovascular | 8 (5.5) | 2 (3.4) | 5 (5.6) | 2 (3.6) |
| Musculoskeletal | 5 (3.4) | 6 (10.4) | 0 | 6 (10.7) |
| Alimentary and metabolism | 2 (1.4) | 1 (1.7) | 2 (2.2) | 1 (1.8) |
| Systemic hormonal preparations | 0 | 1 (1.7) | 0 | 1 (1.8) |
Abbreviations: EMA, European Medicines Agency; FDA, US Food and Drug Administration.