Policy & Regulation
The European Commission approves Bristol Myers Squibb's and Acceleron Pharma's Reblozyl
29 June 2020 -

The European Commission has approved United States-based Bristol Myers Squibb's (NYSE: BMY) and United States-based Acceleron Pharma Inc's (NASDAQ: XLRN) Reblozyl (luspatercept), it was reported on Friday.

The product is intended for the treatment of adult patients with transfusion-dependent anaemia because of very low-, low- and intermediate-risk myelodysplastic syndromes with ring sideroblasts, who had an unsatisfactory response or are ineligible for erythropoietin-based therapy and for adult patients with transfusion-dependent anaemia associated with beta thalassemia.

The product is the first and only erythroid maturation agent approved in the European Union. It has received approval based on the data from the pivotal Phase three MEDALIST and BELIEVE studies, assessing the ability of the product to effectively address anaemia associated with myelodysplastic syndromes and beta thalassemia, respectively.

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