Astellas’ chronic kidney drug shows superiority at Phase 3

pharmafile | September 20, 2018 | News story | Research and Development Astellas, chronic kidney disease, pharma, roxadustat 

Astellas has revealed new Phase 3 data for roxadustat in the treatment of chronic kidney disease (CKD) in patients with anaemia not on dialysis, demonstrating that the drug met its primary endpoint in the ALPS study, which was predominantly conducted across Europe, the Middle East and Africa (EMEA).

The drug, which inhibits hypoxia ­inducible factor (HIF) prolyl hydroxylase activity, showed “superiority in efficacy” over placebo in both haemoglobin (Hb) response rate in the first 24 weeks and Hb change from baseline at Weeks 28 to 52.

“The ALPS study adds to the growing body of evidence to support roxadustat as a potential treatment of anaemia associated with CKD,” said Salim Mujais, M.D, 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 study was the first of three planned Phase 3 studies which together form a wider large-scale global development programme, conducted in partnership with FibroGen, with Astellas hoping to utilise the data they generate to support a regulatory filing of the drug in Europe.  

Matt Fellows

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