ImetelChat

Recently the COMP met to discuss a drug for "discussion and opinion" identified as EMA OD/0000036404 for R/R MF. I don't know if this is Imetelstat or not but there are not a lot of drugs in this category and I supposed it is unnamed for a reason. We know that OD was granted in this indication in 2015 when the drug was sponsored by Janssen. It makes me wonder if the following applies:

"From EMA website: At the time of marketing authorisation, the COMP will check if all criteria for orphan designation are still met. The designated orphan medicinal product should be removed from the Community Register of Orphan Medicinal Products if it is established that the criteria laid down in the legislation are no longer met."

YMB poster Fan has brought these ideas together. Be interesting to see if he/she is right. The EMA designation number could turn out to be for an entirely different drug so I don't want to be misleading but it is worth following to see where it might lead if only out of general interest.

Best Wishes, bp

only July 28 the EMA number assigned to imetelstat was EMA/OD/0000031951 - for Orphan for MDS - thats why I think this discussion might of been regarding another drug - unless the number was changed

Thanks rccola I wondered but didn’t have time to go back and check. Thanks for doing that. bp

rccola, The EU meeting was for MF, not MDS. Don't know if they are assigned different numbers depending on indication. In any case if you want to dig deeper here is the 2015 number assigned to Imetelstat when it was granted OD in 2015. We could be chasing smoke (as usual) but sometimes one can catch a break! 29 January 2016 EMA/COMP/777525/2015
Committee for Orphan Medicinal Products

https://ec.europa.eu/health/documents/c ... /o2305.htm

this is what i saved end of July

There are at least four other drugs under consideration or awarded orphan status for myelofibrosis in the EU, including luspatercept:

https://www.ema.europa.eu/en/search/sea ... 0000036404