European Medicines Agency Committee for Orphan Medicinal Products issues positive opinion on application for orphan drug designation of imetelstat as potential treatment for myelodysplastic syndromes (MDS)

Postive opinion was based on data from phase 2 trial of this first-in-class telomerase inhibitor in lower risk MDS patients who are transfusion dependent and have failed to respond to treatment with erythropoiesis stimulating agents. IMerge phase 3 trial is currently enrolling.


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