25 June 2021 - Astellas Pharma today announced the CHMP of the EMA has adopted a positive opinion relating to the use of roxadustat for the treatment of adult patients with symptomatic anaemia associated with chronic kidney disease.
The positive CHMP opinion is based on the results from a comprehensive pivotal Phase 3 program comprising of eight multicenter and randomised studies, which involved 9,600 patients worldwide.