- Hyperthyroidism develops in patients on dialysis in response to secondary hyperparathyroidism (HPT). As kidney function declines, the parathyroid glands boost thyroid production to maintain normal calcium and phosphorous levels.
- In the latest phase III trial for Amgen's AMG 416, 74% of patients treated with the drug had a greater than 30% decline in PTH levels, versus an 8.3% drop in the placebo-treated group.
- There was a high incidence of adverse treatment-related events in both AMG 416-treated patients and placebo-treated patients.
Amgen's goal for AMG 416 is to introduce a robust treatment option for kidney disease patients on dialysis who develop secondary PTH. Because AMG 416 is delivered intravenously, it is ideal for patients undergoing hemodialysis.
In addition to conducting phase III, placebo-controlled trials, Amgen will also be conducting head-to-head trials against its existing secondary HPT drug, Sensipar (cinacalcet).