MDS


Associated tags: Biotechnology, MDS, Health, Clinical Trials, Pharmaceutical, BMY, Patient, Bristol Myers Squibb, Pharmaceutical industry, Epoetin alfa, Transfusion-dependent anemia, Anemia, RBC, Safety, HB, NYSE, European Medicines Agency, ESA, EMA, Civil service commission

European Commission Expands Approval of Bristol Myers Squibb’s Reblozyl® (luspatercept) to Include First-Line Treatment of Transfusion-Dependent Anemia in Adults with Lower-Risk Myelodysplastic Syndromes (LR-MDS)

Retrieved on: 
Wednesday, April 3, 2024
Biotechnology, Pharmaceutical, Health, Clinical Trials, Civil service commission, BMY, Safety, Patient, Transfusion-dependent anemia, Bristol Myers Squibb, European Commission, Anemia, MDS, Epoetin alfa, Pharmaceutical industry

Bristol Myers Squibb (NYSE: BMY) today announced that the European Commission (EC) has expanded approval of Reblozyl® (luspatercept) to include the first-line treatment of adult patients with transfusion-dependent anemia due to very low, low and intermediate-risk myelodysplastic syndromes (MDS).

Key Points: 
  • Bristol Myers Squibb (NYSE: BMY) today announced that the European Commission (EC) has expanded approval of Reblozyl® (luspatercept) to include the first-line treatment of adult patients with transfusion-dependent anemia due to very low, low and intermediate-risk myelodysplastic syndromes (MDS).
  • This approval of Reblozyl covers all EU member states.
  • Safety results were consistent with previous MDS studies and were in line with expected symptoms in this patient population.
  • Reblozyl is also approved in the United States and Japan for the first-line treatment of anemia associated with lower-risk MDS.

Bristol Myers Squibb Receives Positive CHMP Opinion for Reblozyl® (luspatercept) for Treatment of Adults with Transfusion-Dependent Anemia due to Low- to Intermediate-Risk Myelodysplastic Syndromes (MDS)

Retrieved on: 
Friday, February 23, 2024
Oncology, Health, Other Health, Clinical Trials, Pharmaceutical, Biotechnology, BMY, European Commission, EMA, Committee, Transfusion-dependent anemia, Bristol Myers Squibb, RBC, European, MDS, Civil service commission, CHMP, European Medicines Agency, Patient

The recommendation will now be reviewed by the European Commission (EC), which has the authority to approve medicines for the European Union (EU).

Key Points: 
  • The recommendation will now be reviewed by the European Commission (EC), which has the authority to approve medicines for the European Union (EU).
  • Upon approval, this would represent the fourth authorized indication for Reblozyl in the EU.
  • The CHMP adopted a positive opinion based on results from the pivotal Phase 3 COMMANDS trial.
  • Safety results were consistent with previous MDS studies and were in line with expected symptoms in this patient population.

Bristol Myers Squibb to Present First Results at ASCO and EHA from Phase 3 COMMANDS Study of Reblozyl® (luspatercept-aamt) in First-Line Treatment of Anemia in Adults with Lower-Risk Myelodysplastic Syndromes (MDS)

Retrieved on: 
Thursday, May 25, 2023
Oncology, Health, Other Health, Clinical Trials, Pharmaceutical, Biotechnology, Epoetin alfa, Abstract, The Bristol-Myers Squibb Children's Hospital, RBC, European Hematology Association, ESA, Myelodysplastic syndrome, American Society of Clinical Oncology, Bristol Myers Squibb, EDT, BMY, MD Anderson Cancer Center, ASCO, MDS, Congress, HB, Patient, Risk, University, Anemia, CEST, EHA, Annual general meeting, Death, Safety, Society, NYSE, Pharmaceutical industry

Key secondary endpoints include erythroid response (HI-E) of at least 8 weeks during weeks 1-24 of the study, RBC-TI ≥12 weeks and RBC-TI for 24 weeks.

Key Points: 
  • Key secondary endpoints include erythroid response (HI-E) of at least 8 weeks during weeks 1-24 of the study, RBC-TI ≥12 weeks and RBC-TI for 24 weeks.
  • HI-E increase of at least 8 weeks was achieved by 74.1% (n=109) of Reblozyl patients vs. 51.3% (n=79) of epoetin alfa patients (p
  • Within the first 24 weeks of treatment, RBC-TI of at least 24 weeks was achieved by 47.6% (n=70) of Reblozyl patients vs. 29.2% (n=45) of epoetin alfa patients (P=0.0006).
  • Benefit with Reblozyl was also observed in clinically relevant subgroups, and results showed a consistent safety profile and no new safety signals.

U.S. FDA Accepts for Priority Review Supplemental Biologics License Application and EMA Validates Application for Reblozyl® (luspatercept-aamt) as First-Line Treatment of Anemia in Adults with Lower-Risk Myelodysplastic Syndromes (MDS)

Retrieved on: 
Monday, May 1, 2023
FDA, Health, Clinical Trials, Pharmaceutical, Cardiology, Biotechnology, Epoetin alfa, Bristol Myers Squibb, RBC, Priority review, Failure, ESA, Safety, European Medicines Agency, Transfusion-dependent anemia, Type, BMY, EMA, MDS, HB, Prescription Drug User Fee Act, Acquisition, Patient, Syndrome, Anemia, PDUFA, Merck, Regulation of tobacco by the U.S. Food and Drug Administration, NYSE, Food, Pharmaceutical industry, Luspatercept

In the U.S., the FDA has granted the application Priority Review and assigned a Prescription Drug User Fee Act (PDUFA) goal date of August 28, 2023.

Key Points: 
  • In the U.S., the FDA has granted the application Priority Review and assigned a Prescription Drug User Fee Act (PDUFA) goal date of August 28, 2023.
  • Priority Review designation underscores the high unmet need and value that Reblozyl could bring to this patient population.
  • In Europe, the EMA’s validation of the application confirms the submission is complete and begins the EMA’s centralized review process.
  • Reblozyl is being developed and commercialized through a global collaboration with Merck following Merck’s acquisition of Acceleron Pharma, Inc. in November 2021.