Roxadustat (1) – Evrenzo®
Symptomatic anemia in chronic kidney disease (CKD)
Characteristics
| Start date | 15.09.2021 – Marketing authorisation: 18.08.2021 |
|---|---|
| Resolution | 03.03.2022 |
| INN | Roxadustat |
| Brand name | Evrenzo® |
| Pharm. company | Astellas Pharma GmbH |
| G-BA Procedure ID | D-718 |
| ATC code | B03XA05 Other antianemic preparations (B03XA) |
| DDD | 43 mg O |
| Therapeutic area | Hematopoietic diseases |
| Reason for procedure | Initial assessment |
Studies and Results
- Clinical trials
- The pharmaceutical manufacturer did not submit any suitable data for comparison with the appropriate comparator therapy to assess the additional benefit of roxadustat for the treatment of adults with symptomatic anaemia associated with chronic kidney disease.
Adults with symptomatic anaemia associated withchronic kidney disease(CKD)
- For adults with symptomatic anaemia associated with chronickidney disease(CKD), the additional benefit of roxadustat over the appropriate comparator therapy is not proven.
- For the patient population of adults with symptomatic anaemia associated with chronic kidney disease, the pharmaceutical manufacturer did not submit any data that would have been suitable for assessing the additional benefit of roxadustat compared with the appropriate comparator therapy.
- Overall, an additional benefit of Roxadustat over the appropriate comparator therapy is not proven for this patient population.
Courtesy translation only, please refer to the German original.
Associated procedures
| Roxadustat (1) | Evrenzo® | Astellas Pharma GmbH | Symptomatic anemia in chronic kidney disease (CKD) | 151,000–195,000 | 100% additional benefit not proven |
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