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
傑隆說，歐洲藥品管理局人用藥品委員會已建議批准RYTELO（Imetelstat），用於治療因極低、低或中等風險骨髓增生異常綜合徵而患有輸血依賴性（TD）貧血的成年患者
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.
該公司表示，歐洲藥品管理局（EMA）的人用藥品委員會（CHMP）已通過積極意見，建議批准RYTELO（imetelstat）用於治療因極低、低或中等風險骨髓增生異常綜合徵（LR-MDS）而導致的輸血依賴性（TD）貧血的成年患者，沒有孤立的缺失5q細胞遺傳學（非del 5q）異常和誰對基於促紅細胞生成素的治療反應不令人滿意或沒有資格接受基於促紅細胞生成素的治療。有權批准歐盟（EU）藥品的歐盟委員會（EC）將審查CHMP的建議，並有望在接下來的幾個月內對上市許可申請（MAA）做出最終決定。
