Phase III Roxadustat ALPS Data Positive For New Class Of Anemia Therapies
Positive top-line data from the ALPS study confirms the efficacy and safety of roxadustat, a Phase III-stage product which could be the first a new class of orally active agents with potential in the treatment of anemia associated with chronic kidney disease.
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Positive top-line Phase III data from five studies, including the finding of superior efficacy to epotin-alfa, puts roxadustat in the driving seat as a new class of anemia agents heads toward the marketplace, but cardiovascular safety needs confirming.
China is the first country to give the green light to roxadustat, AstraZeneca and FibroGen's first-in-class oral inhibitor of HIF-PHI, which could become standard of care to treat anemia in chronic kidney disease patients.
Sensipar/Parsabiv marketer Amgen and three developers of new treatments for anemia emphasize importance to innovation of additional payments outside Medicare's reimbursement bundle for end-stage renal disease.