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) - Seite 3

About Reblozyl (luspatercept)

REBLOZYL, a first-in-class therapeutic option, promotes expansion and maturation of late-stage red blood cells in animal models. Reblozyl is being developed and commercialized through a global collaboration and North American co-promotion with Merck following Merck’s acquisition of Acceleron Pharma, Inc. in November 2021.

E.U. Indications:

REBLOZYL is indicated in the E.U. for the treatment of:

• adult patients with transfusion-dependent anaemia due to very low, low and intermediate-risk myelodysplastic syndromes (MDS).
• adult patients with anaemia associated with transfusion-dependent and non-transfusion-dependent beta-thalassaemia.

A European Summary of Product Characteristics for REBLOZYL is available from the European Medicines Agency website at www.ema.europa.eu.

U.S. Indications:

REBLOZYL is indicated in the U.S. for the treatment of:

• anemia in adult patients with beta thalassemia who require regular red blood cell (RBC) transfusions.
• anemia without previous erythropoiesis stimulating agent use (ESA-naïve) in adult patients with very low- to intermediate-risk myelodysplastic syndromes (MDS) who may require regular red blood cell (RBC) transfusions.
• anemia failing an erythropoiesis stimulating agent and requiring 2 or more red blood cell (RBC) units over 8 weeks in adult patients with very low- to intermediate-risk myelodysplastic syndrome with ring sideroblasts (MDS-RS) or with myelodysplastic/myeloproliferative neoplasm with ring sideroblasts and thrombocytosis (MDS/MPN-RS-T).

REBLOZYL is not indicated for use as a substitute for RBC transfusions in patients who require immediate correction of anemia. In the U.S., REBLOZYL is not indicated for use in patients with non-transfusion-dependent beta thalassemia.

U.S. Important Safety Information:

WARNINGS AND PRECAUTIONS

Thrombosis/Thromboembolism

In adult patients with beta thalassemia, thromboembolic events (TEE) were reported in 8/223 (3.6%) of REBLOZYL-treated patients. TEEs included deep vein thrombosis, pulmonary embolus, portal vein thrombosis, and ischemic stroke. Patients with known risk factors for thromboembolism (splenectomy or concomitant use of hormone replacement therapy) may be at further increased risk of thromboembolic conditions. Consider thromboprophylaxis in patients at increased risk of TEE. Monitor patients for signs and symptoms of thromboembolic events and institute treatment promptly.