Bristol-Myers' Reblozyl To Be Reviewed By FDA Committee
Zacks Investment Research | Dec 03, 2019 10:08PM ET
Bristol-Myers Squibb Company (NYSE:BMY) and Acceleron Pharma Inc. (NASDAQ:XLRN) announced that the FDA’s Oncologic Drugs Advisory Committee will hold a review of their supplemental Biologics License Application (sBLA) for Reblozyl (luspatercept-aamt) in patients with myelodysplastic syndromes (MDS) at the meeting on Dec 18.
Bristol-Myers Squibb is seeking approval of Reblozyl for the treatment of adult patients with very low- to intermediate-risk MDS-associated anemia, who have ring sideroblasts and require red blood cell (RBC) transfusions. The FDA has set a target action date of Apr 4, 2020, for the same.
Shares of the company have gained 11.1% year to date compared with the industry ’s growth of 5.7%.
We remind investors that in November, the FDA Reblozyl for the treatment of anemia in adult patients with beta thalassemia, who require RBC transfusions. The drug is the first and only FDA-approved erythroid maturation agent, representing a new class of therapy for these patients. The approval came ahead of the target action date of Dec 4.
Additionally, a phase II study (BEYOND) in adult patients with non-transfusion-dependent beta thalassemia, a phase III study (COMMANDS) in ESA-naïve, lower-risk MDS patients and a phase II study in myelofibrosis patients are ongoing.
We remind investors that Bristol-Myers recently completed the acquisition of Celgene Corporation (NASDAQ:CELG), with an equity value of approximately $74 billion, to boost its oncology franchise.
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