预约演示
EC approves Bristol Myers Squibb’s Reblozyl for first-line MDS treatment
2024-04-03
上市批准临床3期临床结果
The approval for Bristol Myers Squibb’s Reblozyl is applicable in all the EU member states. Katherine Welles / Shutterstock.com.
The European CommBristol Myers SquibbtedReblozyld approval for Bristol Myers Squibb‘s (BMS) Reblozyl (luspatercept) as a first-line treatment for adults with transfusion-dependent anaemia associated with very low, low and intermediate-risk myelodysplastic syndromes (MDS).
The decision is applicable in all the member states of the EuroBristol Myers SquibbReblozylluspatercepttransfusion-dependent anaemiamyelodysplastic syndromes (MDS)
The EC’s expanded approval is based on the results from the open-label, randomised Phase III COMMANDS study.
The trial assessed the efficacy and safety of Reblozyl compared to epoetin alfa, an erythropoiesis-stimulating agent, in treating anaemia due to MDS.
It included subjects who needed red blood cellReblozylransfusions aepoetin alfarevioerythropoiesis-stimulating agentmulating agentanaemiaMDS
See Also:
Alexion’s Voydeya gains FDA approval for extravascular haemolysis
Reblozyl significantly outperformed epoetin alfa in achieving concurrent RBC transfusion independence and a rise in haemoglobin levels – the study’s primary endpoint.
Novartisesults were in line with prevcocaine use disorder with nmavoglurantnt differences in progression to acute myeloid leukaemia or total deaths between the study arms.
This approval is the fourth indication authorised for Reblozyl in Europe, positioning it as a first-in-class treatment for people with disease-related anaemia and the first therapy to demonstrate superior efficacy versus epoetin alfa in lower-risk MDS (LR-MDS).
Reblozyl is a product of a global coepoetin alfaand is co-promoted in North America by Merck (MSD), following its acquisition of Acceleron Pharma in November 2021.
It has also been approved in the US and Japan for theMDSrst-line treatment of anaemia associated with LR-MDSacute myeloid leukaemia
Bristol Myers Squibb European Markets senior vice-presReblozyld head Monica Shaw stated: “With this approval for Reblozyl as a first-lidisease-related anaemiaa in adults with LR MDS, more patients in the EU will have the epoetin alfa become trrisk MDS (LR-MDS)dent for longer periods compared to current options available.
Reblozyllestone underscores our ongoing commitment to developing new options for patienMerckth disease-related anaemia.”Acceleron Pharma
Last month, the EC approved BMS’ Abecma (idecabtagene vicleucel; ide-cel) to tanaemiaults with relapsed and refractory multiple myeloma.
更多内容，请访问原始网站
文中所述内容并不反映新药情报库及其所属公司任何意见及观点，如有版权侵扰或错误之处，请及时联系我们，我们会在24小时内配合处理。
靶点
-药物
生物医药百科问答
全新生物医药AI Agent 覆盖科研全链路，让突破性发现快人一步
立即开始免费试用!
智慧芽新药情报库是智慧芽专为生命科学人士构建的基于AI的创新药情报平台，助您全方位提升您的研发与决策效率。
立即开始数据试用!
智慧芽新药库数据也通过智慧芽数据服务平台，以API或者数据包形式对外开放，助您更加充分利用智慧芽新药情报信息。