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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)

Published: 2024-02-23 11:59:00 ET

Approval by European Commission would expand Reblozyl’s indication to include first-line treatment of anemia in adults with MDSin Europe

In the pivotal Phase 3 COMMANDS study, Reblozyl nearly doubled the percentage of patients achieving primary endpoint of both transfusion independence and hemoglobin increase vs. epoetin alfa

PRINCETON, N.J.--(BUSINESS WIRE)-- Bristol Myers Squibb (NYSE: BMY) today announced the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended approval of Reblozyl® (luspatercept) as a treatment for adult patients with transfusion-dependent anemia due to very low, low and intermediate-risk myelodysplastic syndromes (MDS). 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. Results from the primary analysis showed 60.4% (n=110) of patients treated with Reblozyl vs. 34.8% (n=63) of patients treated with epoetin alfa achieved the primary endpoint of red blood cell (RBC) transfusion independence of at least 12 weeks with a mean hemoglobin increase of at least 1.5 g/dL within the first 24 weeks (p

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All statements made via social media sites sponsored or maintained by Enhanced Investments and its affiliates are for informational purposes only and do not constitute a comprehensive description of Enhanced Investments' investment advisory services.
Certain investments are not suitable for all investors. Before investing, consider your investment objectives and applicable fees. The rate of return on investments can vary widely over time, especially for long term investments. Investment losses are possible, including the potential loss of all amounts invested. Information provided by Enhanced Investments is for informational and general educational purposes only and is not investment or financial advice.