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) |