Insmed Inc (INSM)

[Christiaan F]

You'll find the whole EMEA & COMP process and the advantages it has on this link. http://www.eurordis.org/rubrique.php3?id_rubrique=24
http://www.eurordis.org/article.php3?id_article=440

Orphan medicinal product designation assigns orphan status based on a defined number of criteria. These can be resumed as:

- The product should be intended to be use for an indication concerning no more than 5 in 10 000 persons in the European Community.
- The disease concerned should be life-threatening, seriously debilitating or a serious and chronic condition.
- There should exist no satisfactory method of diagnosis, prevention or treatment of the condition in question that has been authorized in the European Community; or, if such a method exists, then the medicinal product will confer a significant benefit compared to the existing one.

The request for Orphan Medicinal Product designation can be made at any stage of drug development as soon as sufficient scientific evidence can be presented. The request for Orphan Medicinal Product designation can be made at any stage of drug development as soon as sufficient scientific evidence can be presented. The research may therefore be pre-clinical (not yet tested on human subjects) or may have reached the human clinical trial phase.

INSM received positive opinion from he COMP for Iplex as a treatment for:
- IGFD
- Noonan syndrome (even if phase II trial has not been finished yet)


CF