09:03 AM EDT, 04/03/2024 (MT Newswires) -- Bristol-Myers Squibb ( BMY ) said late Tuesday that Reblozyl has received its fourth authorized indication in the European Union, with its approval as a first-line treatment of transfusion-dependent anemia in adults with lower risk myelodysplastic syndromes.

The approval by the European Commission covers all EU member countries, the company said.

The approval was based on the results of the company's pivotal phase 3 trial, in which Reblozyl showed "superior efficacy" against epoetin alfa, while safety data was "consistent" with prior studies, Bristol-Myers said.

The US and Japan have also approved Reblozyl for the first-line treatment of anemia due to lower-risk myelodysplastic syndromes, the biopharmaceutical company said.

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