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Geron's Rytelo Secures European Medicines Agency Committee's Approval Recommendation
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Geron's Rytelo Secures European Medicines Agency Committee's Approval Recommendation
Dec 13, 2024 4:57 AM

07:30 AM EST, 12/13/2024 (MT Newswires) -- 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 ( GERN ) 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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