Geron Says Committee For Medicinal Products For Human Use Of The European Medicines Agency Has Recommended Approval Of RYTELO (Imetelstat) For Treatment Of Adult Patients With Transfusion-dependent (TD) Anemia Due To Very Low, Low Or Intermediate Risk Myelodysplastic Syndromes
Company says Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion recommending the approval of RYTELO (imetelstat) for the treatment of adult patients with transfusion-dependent (TD) anemia due to very low, low or intermediate risk myelodysplastic syndromes (LR-MDS) without an isolated deletion 5q cytogenetic (non-del 5q) abnormality and who had an unsatisfactory response to or are ineligible for erythropoietin-based therapy. The European Commission (EC), which has the authority to approve medicines in the European Union (EU), will review the CHMP's recommendation and is expected to make a final decision on the marketing authorization application (MAA) in the following months.