Table 2.
Key characteristics of new drugs approveda with and without registries 2007 to 2010
| All drugs, N (%) | Registry,b N (%) | Univariate | Multivariate* | ||
|---|---|---|---|---|---|
| Yes | No | OR (95% CI) | OR (95% CI) | ||
| Total | 116 (100) | 43 (37) | 73 (63) | ||
| Drug characteristics | |||||
| Therapeutic area (ATC 1 level) | |||||
| A | 12 (100) | 5 (42) | 7 (58) | 1.9 (0.5;7.5) | |
| B | 12 (100) | 3 (25) | 9 (75) | 0.9 (0.2;4.0) | |
| J | 26 (100) | 12 (46) | 14 (54) | 2.3 (0.8;6.7) | |
| L | 29 (100) | 13 (45) | 16 (55) | 2.2 (0.8;6.2) | |
| Otherc | 37 (100) | 10 (27) | 27 (73) | Ref | |
| Type of molecule | |||||
| Biological | 30 (100) | 15 (50) | 15 (50) | 1.5 (0.4;5.3) | |
| Small molecule | 71 (100) | 22 (31) | 49 (69) | 0.7 (0.2;2.1) | |
| Vaccine | 15 (100) | 6 (40) | 9 (60) | Ref | |
| Level of innovationd | |||||
| A: Important | 7 (100) | 6 (86) | 1 (14) | 16.0 (1.7;147.1) | 10.3 (1.0;103.9) |
| B: Moderate | 42 (100) | 18 (43) | 24 (57) | 2.0 (0.8;4.9) | 1.2 (0.4;3.5) |
| C: Modest | 23 (100) | 7 (30) | 16 (70) | 1.2 (0.4;3.6) | 0.8 (0.2;2.6) |
| Pharm/tech | 44 (100) | 12 (27) | 32 (73) | Ref | Ref |
| Size of safety populatione | |||||
| Median (range) | 1549 (94‐13 000) | 1002 (94‐13 000) | 1811 (119‐10 257) | 1.0 (1.0;1.0); p = 0.11 | |
| Procedural characteristics | |||||
| Orphan medicinal drugf (yes) | 26 (100) | 15 (58) | 11 (42) | 3.0 (1.2;7.4) | 2.8 (1.0;7.5) |
| CAg and ECh registration (yes) | 23 (100) | 13 (57) | 10 (43) | 2.7 (1.1;6.9) | 1.7 (0.6;5.0) |
p < 0.05 in bold type face.
All determinants with p < 0.1 were included in the multivariate analyses.
Date of approval is date of publication of European Decision.
A registry was promised in the European Public Assessment Report (EPAR, as part of the RMP).
Therapeutic area classified using the anatomical main group of the Anatomical Therapeutic and Chemical Code. All drugs that are not classified as A (alimentary tract and metabolism), B (blood and blood forming organs), J (anti‐infectives for systemic use), or L (antineoplastic and immunomodulating agents) are classified as other.
The drug is an important, moderate, modest of pharmacological, or technological innovation.
Size of safety population is the number of patients that have been analyzed in the safety analysis (initial application, in EPAR).
The drug has an orphan status.
The drug was given a conditional approval (CA).
The drug is approved under exceptional circumstances (EC).