Bristol Myers Squibb, Acceleron get FDA nod for Reblozyl to treat anaemia with lower-risk MDS

Bristol Myers Squibb (BMS) and Acceleron Pharma have secured approval from the US Food and Drug Administration (FDA) for Reblozyl (luspatercept-aamt) to treat anaemia in adults with lower-risk myelodysplastic syndromes (MDS).

Myelodysplastic syndromes are a group of closely related blood cancers characterised by ineffective production of healthy red blood cells, white blood cells and platelets, which may cause anaemia and frequent or severe infections.

Reblozyl is claimed to be the first and only erythroid maturation agent (EMA) to treat anaemia failing an erythropoiesis-stimulating agent and requiring two or more red blood cell (RBC) units over eight 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).

BMS haematology global medical affairs vice president Dr Diane McDowell said: "Today’s approval of Reblozyl is an important milestone for a majority of patients with myelodysplastic syndromes who have limited treatment options to address anaemia associated with their disease."

The latest FDA approval was based on data from the pivotal phase 3, randomised, double-blind, placebo-controlled and multi-centre MEDALIST trial

The study is assessing the efficacy and safety of Reblozyl in patients with IPSS-R-defined very low, low and intermediate-risk non-del (5q) myelodysplastic syndromes (MDS) with ring sideroblasts.

According to BMS, a significantly greater proportion of patients securing Reblozyl achieved independence from RBC transfusions for at least eight weeks during the first 24 weeks of the trial compared with those receiving placebo, meeting the study’s primary endpoint.

In November 2019, Reblozyl was approved to treat anaemia in adults with beta thalassemia who need regular RBC transfusions

Acceleron president and CEO Habib Dable said: "We are enormously grateful to the patients, families and caregivers who participated in and supported the Reblozyl clinical trials, and to the researchers at Acceleron and beyond who, more than a decade ago, began this important quest to address patients’ chronic anaemias."

In March, BMS secured approval from the FDA for Opdivo (nivolumab) 1mg/kg plus Yervoy (ipilimumab) 3mg/kg to treat patients with hepatocellular carcinoma (HCC) earlier treated with sorafenib.

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