Amgen has announced new clinical trial data showing the effectiveness of its drug Parsabiv in the treatment of secondary hyperparathyroidism (sHPT).
Data from three phase III studies demonstrated the investigational intravenous calcimimetic agent's strong performance in more than 1,700 adult sHPT patients on haemodialysis, showing that it produced significant reductions in serum parathyroid hormone (PTH) levels - a key marker of sHPT.
“Amgen has announced new study data showing how its drug Parsabiv can offer benefits for adults with secondary hyperparathyroidism receiving haemodialysis.“
In the first two parallel phase III studies, Parsabiv met the primary endpoint and was shown to significantly reduced serum PTH by more than 30 percent in 74.7 percent of patients, compared to 8.9 percent in those given placebo.
Meanwhile, the third study - a head-to-head trial comparing Parsabiv to an established alternative - also met its primary goal, with Amgen's drug proving a superior performance in terms of PTH reduction.
Dr Sean Harper, executive vice-president of research and development at Amgen, said: "We are encouraged by this data, as it demonstrates improvements in key biomarkers for sHPT and supports its potential for a disease that has not seen any advances in more than a decade."
The European Commission approved Parsabiv for the treatment of sHPT in adult patients with chronic kidney disease on haemodialysis last November.
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