After an initial rejection due to safety issues, followed by a dispute and deferred actions, Akebia Therapeutics on Wednesday finally won the FDA’s nod for vadadustat as a treatment for anemia caused by chronic kidney disease.
Tag Archive for: anemia
The injectable drug imetelstat was being studied in patients with lower risk myelodysplastic syndromes (MDS), a type of blood cancer, which requires frequent blood transfusions for managing anemia.
AstraZeneca on Monday shut down the bulk of its roxadustat partnership with FibroGen, returning the rights to develop and commercialize the investigational HIF-PH inhibitor in the U.S. and other AstraZeneca territories to the biotech.
The Swiss pharma’s Fabhalta, a Factor B inhibitor, is the first FDA-approved oral monotherapy for adults with the rare, chronic blood disorder paroxysmal nocturnal hemoglobinuria.
BMS pushed back by a year the time frame for its current new-product portfolio to hit $10 billion in sales as the ramp-up of new drugs including anemia treatment Reblozyl, psoriasis drug Sotyktu, and multiple sclerosis drug Zeposia takes longer than expected.
Following a regulatory victory for Jemperli in endometrial cancer last month, GSK continues its oncology winning streak with an FDA approval for momelotinib in myelofibrosis with anemia.
Akebia Therapeutics scored a long-awaited win Tuesday when it announced the FDA has granted a path forward for vadadustat in anemia associated with chronic kidney disease in dialysis-dependent patients, which will not require the company to submit new data.
The miss is the latest setback for the company whose application seeking approval for the drug to treat anemia in kidney disease patients was rejected by the U.S. Food and Drug Administration in 2021 seeking additional data.
Akebia Therapeutics announced another delay Tuesday in a series of setbacks for vadadustat, being developed to treat anemia linked to chronic kidney disease (CKD).
The U.S. Food and Drug Administration (FDA) on Wednesday approved GSK Plc’s drug as the first oral treatment for anemia caused by chronic kidney disease in adults who have been on dialysis for at least four months.