Table 1.
Characteristics of novel drugs approved by the FDA based on pivotal trials using surrogate markers of disease between 2005 and 2012 with at least one matched controlled postapproval study
| Characteristic | N (%) |
|---|---|
| Total indications | 27 (100.0) |
| Agent type | |
| Pharmacologic | 24 (88.9) |
| Biologic | 3 (11.1) |
| Orphan status | |
| No | 24 (88.9) |
| Yes | 3 (11.1) |
| Approval pathway | |
| Regular | 24 (88.9) |
| Accelerated | 3 (11.1) |
| Priority review | |
| Standard | 19 (70.4) |
| Priority | 8 (29.6) |
| Therapeutic area | |
| Cardiovascular disease, diabetes mellitus | 11 (40.7) |
| Infectious disease | 6 (22.2) |
| Cancer | 2 (7.4) |
| Other | 8 (29.7) |