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Amgen reports positive clinical trial data for etelcalcetide
Amgen has announced positive clinical data for its novel calcimimetic agent etelcalcetide during the American Society of Nephrology's Kidney Week.
The head-to-head phase III study compared intravenous etelcalcetide with oral cinacalcet for the treatment of secondary hyperparathyroidism (SHPT) in adult patients with chronic kidney disease (CKD) receiving haemodialysis.
It was shown that etelcalcetide was able to meet its primary endpoint of noninferiority compared to cinacalcet, helping to reduce patients' levels of pre-dialysis serum intact parathyroid hormone between weeks 20 and 27.
Etelcalcetide works by suppressing the secretion of parathyroid hormone and is in clinical development for the treatment of SHPT in patients with CKD on haemodialysis.
Dr Sean Harper, executive vice president of research and development at Amgen, said: "We believe etelcalcetide has the potential to be an important new treatment option, and we look forward to working with regulatory authorities to bring this novel intravenous calcimimetic to market."
The drug was accepted for US regulatory review last week.
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