FDA and NICE approve of first new hyperparathyroidism drug in 12 years

The FDA has given the go-ahead for Amgen’s hyperparathyroidism (HPT) therapy Parsabiv (etelcalcetide), marking the first new treatment for patients of the disease in twelve years.

NICE has also recommended its use in the same indication when provided at a discount through a patient access scheme or when previously-approved drug Sensipar (cinacalcet) is not a suitable treatment.

Parsabiv is indicated for the treatment of secondary HPT in adult patients suffering from chronic kidney disease (CKD) who are on haemodialysis. The calcimimetic therapy is the first and only treatment for the condition that can be delivered intravenously by the haemodialysis healthcare team.

Secondary HPT is a serious disease which occurs when the parathyroid glands produce high levels of parathyroid hormone (PTH) as a response to inhibited renal function as a result of advanced CKD. Almost nine out of ten CKD patients undergoing haemodialysis will develop the ailment, though it is known to be underdiagnosed.

Parsabiv works to rectify this by activating the gland’s calcium receptors, which in turn brings down levels of the hormone. In two recent studies, the drug showed more than a 30% reduction in PTH from baselineversus placebo.

Amgen’s Executive Vice President of Research and Development Sean E. Harper commented on the FDA’s approval, noting: "We are excited about today's approval of Parsabiv in the US 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 haemodialysis. 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 health care professional."

NICE meanwhile calculated Parsabiv’s QALY at £14,778 versus current treatment cinacalcet at £26,647. The drug was previously approved in the EU in November last year.