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.
AbbVie's ELAHERE receives full US FDA approval
Johnson & Johnson's OPSYNVI receives US FDA approval
Outlook Therapeutics receives positive CHMP opinion for ONS-5010 in wet AMD treatment
Human Immunology Biosciences receives ODD from FDA for felzartamab
Eton Pharmaceuticals acquires PKU GOLIKE, expanding rare disease portfolio
Vertex receives FDA clearance for VX-407 Investigational New Drug Application for ADPKD
Phanes Therapeutics receives FDA Fast Track designation for PT886
Bio-Thera Solutions signs new licensing agreement with SteinCares
FDA accepts resubmission of Citius Pharmaceuticals, Inc's BLA for LYMPHIR
GSK Plc reports positive Phase III Jemperli data for endometrial cancer
ImmVira receives FDA Fast Track designation for MVR-T3011 IT