08-05-07

EMP participates in EMEA Talks concerning the Approval of Revlimid and Thalidomide

On March 22, 2007, the EMEA (European Medicines Agency), in its scientific committee CHMP (Committee for Medicinal Products for Human Use), has issued a positive opinion recommending the marketing authorisation for Revlimid.

During the preceding months multiple myeloma patient representatives of EMP have been actively involved in the marketing authorisation procedure for Revlimid at the EMEA.

Revlimid is a medicine containing the active substance lenalidomide. It is to be used as a promising and powerful oral treatment for multiple myeloma patients. Lenalidomide has a chemical structure that resembles that of thalidomide. Thalidomide is “teratogenic”, meaning that it has a harmful effect on the unborn child. During the development of Revlimid, extensive tests were carried out to find out whether lenalidomide has the same teratogenic effects. Although lenalidomide’s effects were limited in comparison with thalidomide, the studies were not sufficient to rule out completely a risk of lenalidomide also being teratogenic.

As part of the marketing authorisation for Revlimid, the CHMP has requested that a number of measures be put in place to minimise any risk of damage to unborn children of patients taking Revlimid by setting up a “Risk Management Plan”.

In this context, associations of thalidomide victims and patient representatives were consulted so that their views could be taken into account.

EMP was strongly represented at those meetings by our members Mrs. Ilse Hein (Austria), Mrs. Doris Mayerböck (Austria) and Mrs. Greetje Goossens (Belgium) all of them being multiple myeloma patients themselves. As patients they embrace this new medicine on a deeply personal level because it gives MM patients hope to continue with a new promising treatment.

EMP has been working hard together with the victim groups and the CHMP and contributed positively to the development of the Risk Management Plan and to the contents of the Package Leaflet.

Now that the positive recommendation for the marketing authorisation for Revlimid has been granted, we look forward having this new medicine available as soon as possible for our fellow Multiple Myeloma patients and this in an environment of safe prescription and distribution. We are pleased that as a true "patients-for-patients" platform for Multiple Myeloma, we were able to contribute to the accessibility of this new promising medicine.