Trial Profile
A Phase 3, Long Term Study of Intermittent Oral Dosing of ASP1517 in Hemodialysis Chronic Kidney Disease Patients With Anemia Converted From Erythropoiesis Stimulating Agent Treatment
Status:
Completed
Phase of Trial:
Phase III
Latest Information Update: 17 Sep 2021
Price :
$35
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At a glance
- Drugs Roxadustat (Primary)
- Indications Anaemia
- Focus Registrational; Therapeutic Use
- Sponsors Astellas Pharma
- 20 Sep 2019 According to a FibroGen media release, Japan's Ministry of Health, Labour and Welfare (MHLW) approved roxadustat for the treatment of anemia associated with chronic kidney disease (CKD) in dialysis patients.
- 08 Aug 2019 According to a FibroGen media release, the regulatory decision for roxadustat approval in Japan is expected in the second half of 2019.
- 22 Feb 2019 According to a FibroGen media release, NDA is under review by the Pharmaceuticals and Medical Devices Agency (PMDA).