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Home Industry News Amgen’s Parsabiv receives FDA approval for treating chronic kidney disease patients

Amgen’s Parsabiv receives FDA approval for treating chronic kidney disease patients

13th February 2017

Amgen has received approval from the US Food and Drug Administration (FDA) for its chronic kidney disease drug Parsabiv following an initial rejection.

The authority has deemed the treatment suitable for patients suffering from secondary hyperparathyroidism as a result of their chronic kidney disease who are already receiving haemodialysis.

Phase III trials involving Parsabiv showed that more than three-quarters (77 to 79 percent) of chronic kidney disease patients treated with the drug showed a marked reduction in the function of their parathyroid (PTH) glands compared to placebo.

In kidney disease patients, these glands can begin producing abnormal levels of calcium and phosphorus by the time the individual is in need of dialysis, further weakening their health.

However, the trial results suggest that Parsabiv is able to go some way towards stabilising this, potentially improving outcomes and quality of life for patients, as well as preventing the development of some of the side effects associated with excess calcium and phosphorus levels, which can include a weakening of the bones.

Sean E Harper, executive vice-president of research and development at Amgen, commented: "Parsabiv not only has demonstrated strong efficacy in clinical trials; it also fills an unmet need by putting the delivery of the therapy in the hands of the healthcare professional."

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