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Page 9 of 9 For all of three products, symptoms claims (including fatigue and nausea) were approved in both European and the US labeling. For fluticasone furoate, EMEA labeling reports an improvement in the patient's perception of overall response to therapy that is not reported in the FDA label. HRQL claims are also found in both approvals for 2 of the 3 products reviewed. HRQL was measured using the EORTC QLQ-C30 questionnaire for the eculizumab approval and the Rhinitis Quality of Life Questionnaire (RQLQ) for the fluticasone furoate approval. In addition, the FDA approved label includes claims regarding an improvement of HRQL measured with the Functional Living Index - Emesis (FLIE). Similar claims were not reported in the EMEA approved Summary of Product Characteristics (SPC). Indeed, the clinical studies submitted to the EMEA show that the proportion of patients with no impact of CINV on daily life was statistically significant higher in the treatment group compared to the standard therapy group, but this finding is not reported in the SPC. Conclusion
The extension of coverage of FDA decisions for the PROLabels database allows a clearer picture of the use of PRO endpoints and their acceptance in assessing treatment benefits. Evidence based on PRO endpoint has appeared in 20 to 21% of European and American medical product approvals in 2008. When European and American approvals are compared, there is a high degree of similarity between the conclusions of both agencies.
Overall, the PROLabels database provides:
- Easy access to up to date information regarding PRO claims and the instruments used as endpoints to support the claims in approved labels for both the FDA and EMEA in one location
- Summary information and trends in PRO claims in the US and Europe. In particular, this database facilitates the examination of similarities or discrepancies between FDA and EMEA.
- Researchers and manufacturers with strategic information about how competitors have differentiated their products based on PRO results. The database also provides information about successful trial designs including PRO endpoints.
Contact
Martine CARON
MAPI Research Trust - 27, rue de la Villette - 69003 LYON - FRANCE
Tel: +33(0)472 136 575
e-mail:
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