BMS Gets FDA Label Expansion for Potential Mega Blockbuster Reblozyl

2023-08-29

临床3期临床结果上市批准申请上市

Pictured: Bristol Myers Squibb in NJ/iStock, arlutz73 Bristol Myers Squibb is advancing towards its $4 billion-plus sales aspirations for Reblozyl with another indication added to its label. Monday, BMS announced that the FDA bumped up the therapy to a first-line treatment option for anemia in adults with low- to intermediate-risk myelodysplastic syndromes who may require regular blood transfusions. Reblozyl, a recombinant fusion protein designed to suppress the Smad2/3 signaling pathway to increase red blood cell counts, was first authorized in 2019 for anemia in beta-thalassemia. The therapy, co-marketed with Merck, was approved for myelodysplastic syndromes (MDS)-related anemia in 2020 but only in patients who had failed to respond to an erythropoiesis-stimulating agent (ESA), the historically front-line treatment. The label expansion was backed by data from the Phase III COMMANDS study, which put BMS’ therapy head-to-head with the ESA standard of care treatment. Over 58% of patients treated with Reblozyl achieved transfusion independence compared to 31% of patients receiving epoetin alfa, the ESA drug manufactured by Amgen and Johnson & Johnson marketed as Epogen and Procrit, respectively. The trial also proved the drug was effective in patients with and without ring sideroblasts—blood cells with iron deposits circling the nucleus. Previous approval had limited the drug’s use to MDS patients exhibiting this common symptom. “Reblozyl is the first and only therapy to demonstrate superiority compared to an erythropoiesis stimulating agent (ESA) in MDS-related anemia,” according to the company’s press release. BMS has high hopes for the therapy. Second-quarter 2023 sales came in at $234 million. As the company works to add more indications to the drug’s label, BMS is projecting sales of over $4 billion by 2030. Reblozyl is also in a Phase III trial for myelofibrosis patients with myeloproliferative neoplasm slated for a readout in 2025. However, competition may be heating up in the MDS market as Geron Corporation submitted its NDA earlier this month for a first-in-class telomerase inhibitor to treat transfusion-dependent anemia with lower risk MDS. Tested in a Phase III trial against a placebo, imetelstat showed significantly higher results in the eight-week transfusion independence endpoint. “The majority of patients with MDS experience chronic anemia and require RBC transfusions,” Tracey Iraca, executive director of the MDS Foundation, said in the BMS press release. “The approval of Reblozyl in the first-line treatment of anemia for patients with lower-risk MDS represents a crucial step in making transfusion independence possible for more patients.” Kate Goodwin is a freelance life science writer based in Des Moines, Iowa. She can be reached at kate.goodwin@biospace.com and on LinkedIn.

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