From: Does market exclusivity hinder the development of Follow-on Orphan Medicinal Products in Europe?
Category of significant benefit | Classes of significant benefit | Assumptions | |
---|---|---|---|
 |  | N = 130 | % |
Improved efficacy | Different mechanism of action | 47 | 36.2 |
 | Sub-group (including patients who do not respond |  |  |
 | on current treatments) | 27 | 20.8 |
 | Alternative/additional treatment | 14 | 10.8 |
 | Improve the long-term outcome of the patient | 12 | 9.2 |
 | More effective (unspecified) | 10 | 7.7 |
 | Improve the treatment (unspecified) | 1 | 0.8 |
 | Total | 111 | 85.5 |
Improved safety | Fewer side effects | 5 | 3.8 |
 | Increased tolerability | 2 | 1.5 |
 | Improved safety (unspecified) | 2 | 1.5 |
 | Total | 9 | 6.8 |
Contribution to patient care | Mode of administration | 9 | 6.9 |
 | Wider availability | 1 | 0.8 |
 | Total | 10 | 7.7 |