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FDA Approves Amgen, Inc. (AMGN) Drug For Treating Secondary Hyperparathyroidism

Etelcalcetide, an Amgen, Inc. (NASDAQ:AMGN) drug that is meant to treat secondary hyperparathyroidism has been approved by the U.S. Food and Drug Administration. The drug is designed to treat adult patients suffering chronic kidney disease while they are undergoing dialysis. Parsabiv will the brand name for the drug.

“We are excited about today’s approval of Parsabiv in the U.S. and the opportunity to provide patients and health care providers with a novel option to help treat a complex disease that affects a significant number of patients on hemodialysis,” Amgen, Inc. (NASDAQ:AMGN)’s executive vice president of Research and Development, Sean E. Harper said.

Intravenous Administration Of Parsabiv

This will be the first new therapy that has received approval for the chronic kidney disease in more than a decade. The prescribed dosage for the drug is three times a week after a dialysis session. Parsabiv is supposed to be administered intravenously.

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A large percentage of patients with a kidney condition and undergoing dialysis suffer from secondary hyperparathyroidism – a serious chronic condition brought about by decreased kidney function and characterized by excessive secretion of the parathyroid hormone. The purpose of Parsabiv is to reduce the levels of parathyroid hormone by activating calcium-sensing receptors on the parathyroid gland.

26-Week Study Prior To Approval

Parsabiv’s approval by the FDA followed two studies which were placebo-controlled and which took 26 weeks. There were 1,023 patients who took part in the study. All the patients were on hemodialysis and were all suffering from moderate-to-severe secondary hyperparathyroidism. The patients who received Parsabiv and those who received the placebo were randomly selected. Both studies had as their primary endpoint the goal of finding out the proportion of patients who could achieve a reduction of parathyroid hormone to a level of about 30 percent.

At the end of the study, the patients who had been receiving Parsabiv intravenously were able to reduce the levels of parathyroid hormone by more than 30 percent which was significantly more than those who had been receiving a placebo.

In Tuesday’s trading session, shares of Amgen, Inc. (NASDAQ:AMGN) rose by 0.14 percent to close the day at $166.82.

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Note: This article is written by Andy Parker and originally published at Market Exclusive.

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