Reblozyl (luspatercept)
- Region
- 🇪🇺 EU
- Active substance
- luspatercept
- Company
- Bristol Myers Squibb Pharma EEIG
- Status
- Authorised
- Therapeutic area
- Anemia; Myelodysplastic Syndromes; beta-Thalassemia
- CHMP opinion
- Thu 30 Apr 2020
- EU approval
- Thu 25 Jun 2020
- Designations
- Orphan, Additional monitoring
- Application
- EMEA/H/C/004444
- ATC
- B03XA06
- Official record
- www.ema.europa.eu
Indication
Reblozyl is indicated in adults for the treatment of transfusion-dependent anaemia due to very low, low and intermediate-risk myelodysplastic syndromes (MDS).Reblozyl is indicated in adults for the treatment of anaemia associated with transfusion dependent and non transfusion dependent beta thalassaemia. Reblozyl is indicated in adults for the treatment of transfusion-dependent anaemia due to very low, low and intermediate-risk myelodysplastic syndromes (MDS).Reblozyl is indicated in adults for the treatment of anaemia associated with transfusion dependent and non transfusion dependent beta thalassaemia.
Regulatory milestones
Reblozyl: PDUFA target action date (myelofibrosis-associated anemia in adults receiving red blood cell transfusions, with concomitant JAK inhibitor therapy)
Bristol Myers Squibb Co (BMY); luspatercept; sBLA; status: set; "The FDA granted a Prescription Drug User Fee Act (PDUFA) date of March 11, 2027."; filed 2026-07-30 · source
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Information from official EMA, FDA, Federal Register and SEC records. Dates marked company-announced come from the company's own SEC filing; dates marked estimate are calculated, not official. Not investment or medical advice; always confirm on the source.