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...
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...
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
傑龍表示，歐洲藥品管理局人用藥品委員會已推薦批准RYTELO（伊美替斯）用於治療依賴輸血的成年患者，該病患者因低風險或中等風險的骨髓增生異常綜合症（MDS）而導致貧血。
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.
公司表示，歐洲藥品管理局（EMA）人用藥品委員會（CHMP）已通過積極意見，建議批准RYTELO（伊美替斯）用於治療因極低、低或中等風險骨髓增生異常綜合症（LR-MDS）導致依賴輸血的成年患者，該患者沒有孤立的5q缺失細胞遺傳學（非del 5q）異常，並且對紅細胞生成素治療反應不佳或不適合接受該治療。歐洲委員會（EC）有權批准歐盟（EU）內的藥物，將審查CHMP的推薦，並預計在未來幾個月對市場授權申請（MAA）做出最終決定。
譯文內容由第三人軟體翻譯。
