Request Demo
EC approves Bristol Myers Squibb’s Reblozyl for first-line MDS treatment
03 Apr 2024
Drug ApprovalPhase 3Clinical Result
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.
For more details,please visit the original website
The content of the article does not represent any opinions of Synapse and its affiliated companies. If there is any copyright infringement or error, please contact us, and we will deal with it within 24 hours.
Indications
Targets
-AI Agents Built for Biopharma Breakthroughs
Accelerate discovery. Empower decisions. Transform outcomes.
Hot reports
Get started for free today!
Accelerate Strategic R&D decision making with Synapse, PatSnap’s AI-powered Connected Innovation Intelligence Platform Built for Life Sciences Professionals.
Start your data trial now!
Synapse data is also accessible to external entities via APIs or data packages. Empower better decisions with the latest in pharmaceutical intelligence.