A Phase III study assessing Astellas’ roxadustat in patients with chronic kidney disease (CKD) and anaemia who are not receiving dialysis has met its key endpoints.
According to the company, the drug demonstrated superiority in efficacy versus placebo in terms of both haemoglobin response rate in the first 24 weeks and Hb change from baseline at weeks 28 to 52.
Also of note, the preliminary safety analysis shows “an overall event profile consistent with the results seen in previous roxadustat studies” in patients with CKD and anaemia.
“The ALPS study adds to the growing body of evidence to support roxadustat as a potential treatment of anemia associated with CKD,” said Salim Mujais, senior vice president and global therapeutic area head, Medical Specialties Development, Astellas.
“This condition can have a debilitating impact on the patients affected, and we look forward to continuing our work to potentially make a new therapeutic option available to the physicians who care for them.”
The firm said it expects to report further detailed data from the study in the future.
