Geron (GERN) late Tuesday said European regulators have approved its drug candidate Rytelo as a monotherapy to treat adult patients with transfusion-dependent anemia resulting from certain types of lower-risk myelodysplastic syndromes.
According to the company, many patients with anemia of such type often become dependent on red blood cell transfusions, which can be associated with clinical consequences and decreased quality of life. Rytelo is monotherapy for such patients and those who had an unsatisfactory response to or are ineligible for erythropoietin-based therapy.
A European Commission panel previously designated Rytelo as an orphan drug, providing Geron with ten years of market exclusivity and patent protections extending until 2038, subject to approval by the European Patent Office.
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