Table 2.
US Food and Drug Administration and European Medicines Agency approvals of drugs and biologics for complications associated with pediatric CKD
| Indication | FDA | EMA |
|---|---|---|
| All | 35 | 16 |
| Anemia: Erythropoiesis-simulating agents | 3 | 4 |
| Anemia: Iron agents specifically approved for iron deficiency anemia in CKD | 2 | 0 |
| Genetic diseases with kidney manifestations | 8 | 6 |
| Growth failure | 2 | 2 |
| Hyperkalemia | 1 | 0 |
| Hyperphosphatemia | 1 | 1 |
| Hypertension | 16 | 2a |
| Secondary hyperparathyroidism | 2 | 1 |
Approvals of drugs and biologics listed in Supplemental Tables 1 and 2. FDA, Food and Drug Administration; EMA, European Medicines Agency.
a
In the European Economic Area, antihypertensive drugs are authorized mainly on a national level and these are not included.