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Table 4 Assumptions of significant benefit of the follow-on OMPs for which development was continued

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