Geron (GERN) said Friday that the European Medicines Agency's Committee for Medicinal Products for Human Use has recommended the approval of Rytelo for the treatment of adult patients with transfusion-dependent anemia due to lower risk myelodysplastic syndromes.
The company said the committee considered the data from a phase 3 clinical trial, where Rytelo reduced patients' need for red blood cell transfusions in the first 24 weeks of treatment, compared with placebo.
Geron said the European Commission is set to review the committee's recommendation and is expected to issue its final decision on the marketing authorization application in the coming months.
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