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) |
| ICD-10 codes (AIS) | N18.3Chronic kidney disease, stage 3 (moderate), N18.4Chronic kidney disease, stage 4 (severe), N18.5Chronic kidney disease, stage 5, N18.9Chronic renal disease |
| Alpha-ID codes (AIS) | I115950Chronic kidney disease, stage 5, I115953Chronic kidney disease, stage 3, I115954Chronic kidney disease, stage 4, I87179Chronic kidney disease |
| DDD | 43 mg O |
| Therapeutic area | Hematopoietic diseases Anemia / Haemolytic anemia |
| Reason for procedure | Initial assessment |
| Therapeutic indication of the resolution |
|---|
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Evrenzo is indicated for treatment of adult patients with symptomatic anaemia associated with chronic kidney disease (CKD) |
| Subpopulation | Indication | Comparator |
|---|---|---|
| Adults with symptomatic anaemia associated with chronic kidney disease (CKD) | An erythropoiesis-stimulating agent (ESA) (darbepoetin alfa or epoetin (alfa, zeta) or epoetin beta or epoetin theta or methoxy-PEG-epoetin beta) |
Studies and Results
|
No. of studies
(best subpopulation) |
0 (no data submitted) |
|---|---|
|
Study design
(best subpopulation) |
no data submitted |
- 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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