April 6 Quick Takes: Second anemia approval for BMS, Acceleron therapy; plus EU approves trio of metabolic disease drugs, Dicerna-Alnylam and Axsome
Reblozyl gets second approval
FDA approved Reblozyl luspatercept-aamt from Bristol Myers Squibb Co. (NYSE:BMY) and Acceleron Pharma Inc. (NASDAQ:XLRN) to treat anemia in certain patients with myelodysplastic syndromes. It is the second indication for the erythroid maturation agent, which FDA approved in November to treat anemia in β thalassemia patients who require red blood cell transfusions. BMS gained the drug through its takeout of Celgene Corp.
EU approves Novo Nordisk, Esperion drugs for metabolic disease
The European Commission approved Rybelsus from Novo Nordisk A/S (CSE:NOVO B; NYSE:NVO) as an adjunct to diet and exercise to improve glycemic control in adults with Type II diabetes. The oral formulation of long-acting GLP-1 analog semaglutide is also approved in the U.S. and Switzerland and is under review by other regulatory agencies including Japan’s Pharmaceutical and Medical Devices Agency (PMDA)...