Amgen Hormone-Imbalance Drug shows Positive Results in Late-Phase Study

Thursday, Feb 26, 2015

A late-phase clinical study of Amgen Inc.’s experimental treatment for secondary hyperparathyroidism in patients with chronic kidney disease showed a higher percentage of patients responded to its treatment.

The 683-patient study compared results of patients who received Amgen’s AMG 416 against those treated with calcium-lowering cinacalcet, which is marketed in North America by Amgen under the brand name Sensipar.

The therapy aims to treat secondary hyperparathyroidism, a hormonal imbalance common in patients who are on dialysis.

The biopharmaceutical company acquired AMG 416 as part of its $315 million acquisition of KAI Pharmaceuticals in July 2012.

The study met the primary endpoint of at least matching the percentage of patient’s whose parathyroid hormone, or PTH, levels dropped by more than 30% from pre-dialysis levels between weeks 20 and 27 of treatment.

Amgen said 68.2% of those treated with AMG 416 lowered their PTH levels by more than 30%, compared with 57.7% of those treated with cinacalcet. Further, Amgen said, 52.4% of those treated with AMG 416, compared with 40.2% of those treated with cinacalcet, saw their PTH levels drop by more than 50%.

Most patients in the study reported some adverse effects, including decreased blood calcium, nausea, diarrhea and heart failure.


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