Posted by Michael Wonder on 22 May 2020
European Medicines Agency accepts Astellas’ marketing authorisation application for roxadustat
21 May 2020 - Submission for the treatment of anaemia in adult patients with chronic kidney disease.
Astellas and FibroGen today announced the marketing authorisation application for roxadustat for the treatment of anaemia in adult patients with chronic kidney disease has been accepted by the European Medicines Agency for regulatory review.
The application is supported by positive results from a pivotal Phase 3 program, which involved more than 9,000 patients worldwide.
