Amgen has announced positive findings from a head-to-head phase III study evaluating its drug AMG 416 for the treatment of secondary hyperparathyroidism in patients with chronic kidney disease receiving haemodialysis.
The study met its primary endpoint of achieving non-inferiority of AMG 416 compared to an alternative, as defined by the achievement of a greater than 30 percent reduction from baseline in mean pre-dialysis serum intact parathyroid hormone (PTH) levels.
“Amgen has reported clinical trial data demonstrating the efficacy of a new therapy for secondary hyperparathyroidism in patients with chronic kidney disease.“
Moreover, AMG 416 was shown to be significantly superior in terms of the proportion of patients achieving PTH reductions of greater than 50 percent. Additionally, there was no difference between the treatment arms in the mean number of days of vomiting or nausea per week in the first eight weeks.
These results reinforce the previous findings of two positive placebo-controlled studies involving more than 1,000 patients.
Dr Sean Harper, executive vice-president of research and development at Amgen, said: "We are committed to building upon our leadership in nephrology to provide patients with an innovative therapy that can be administered intravenously along with haemodialysis."
This comes after the firm reported positive phase III clinical trial data demonstrating the efficacy of a new biosimilar treatment for rheumatoid arthritis last month.See all the latest jobs in Pharmaceutical