Bristol Myers/Acceleron's Reblozyl Label Expansion Gets FDA Nod

Bristol Myers Squibb Company BMY and partner Acceleron Pharma Inc. XLRN announced that the FDA has approved a label expansion of Reblozyl (luspatercept-aamt).

The drug has been approved for the treatment of 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 syndromes with ring sideroblasts (MDS-RS) or with myelodysplastic/myeloproliferative neoplasm with ring sideroblasts and thrombocytosis (MDS/MPN-RS-T).

FDA’s approval for this indication was based on results from the pivotal phase III MEDALIST study. Per the company, this marks the first new treatment option in over a decade for patients of this indication.

We remind investors that the drug was approved in November 2019 for the treatment of anemia in adults with beta thalassemia who require regular RBC transfusions.

The label expansion of the drug should boost sales potential of the drug and significantly boost Acceleron’s growth prospects.

We note that Bristol Myers also submitted a Marketing Authorization Application (“MAA”) to the European Medicines Agency (EMA). The MAA has been successfully validated and a decision by the EMA is expected in the second half of 2020.

Bristol Myers is currently conducting a phase II study, BEYOND, on luspatercept-aamt in non-transfusion-dependent beta-thalassemia patients. The company expects to release preliminary top-line results are currently expected by the end of 2020. It also plans to conduct a phase III study, COMMANDS, in first-line, lower-risk MDS patients. In myelofibrosis, Bristol Myers is conducting a phase II study in patients with myelofibrosis-associated anemia. Initial results from this study showed that luspatercept-aamt improved anemia in patients receiving and not receiving RBC transfusions with more profound effects in patients treated with Incyte’s INCY Jakafi. Both the companies plan to initiate a phase III study, INDEPENDENCE, in patients with myelofibrosis-associated anemia who are being treated with JAK inhibitor therapy and require RBC transfusions.

The drug was added to Bristol Myers portfolio following Celgene’s acquisition in November 2019 and the label expansion of the drug will likely drive sales. Bristol Myers is responsible for paying 100% of the development costs for all studies for luspatercept-aamt.

Bristol Myers’ shares have declined 10.2% so far this year compared with the industry’s fall of 10.6%.

Both Bristol Myers and Acceleron currently carry a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.

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