Amgen’s Parsabiv gets EC approval for treating SHPT

American biopharma company Amgen’s Parsabiv drug has been approved by the European Commission for treating secondary hyperparathyroidism.

Secondary Hyperparathyroidism (sHPT) is a serious and chronic condition that affects millions of people throughout the world who are undergoing dialysis.

Etelcalcetide branded as Parsabiv is intended to be used in adult patients with chronic renal disease, on hemodialysis.

Parsabiv according to the drugmaker is a calcimimetic agent that has to be administered thrice a week at the end of hemodialysis intravenously by the health care provider.

University College London Medical School professor of nephrology John Cunningham, MD said: “Keeping relevant lab values in recommended target ranges is an important part of managing sHPT, a chronic and complex disease with an already complicated medication regimen for many patients.

“Treatment failures are quite common and Parsabiv provides a new tool that should give physicians more confidence that patients are getting the medication they need to treat their sHPT.”

Parsabiv was approved by EC based on its three Phase 3 studies. All the Phase 3 studies have met their primary endpoints that include two pooled placebo-controlled trials in over 1000 patients and head-to-head study with cinacalcet.

Etelcalcetide has produced secondary endpoints in major proportion of patients to achieve more than 30% and had shown 50% reduction in mean parathyroid hormone during the Efficacy Assessment Phase (EAP) when compared with baseline. Etelcalcetide is found more superior to cinacalcet by this test.

Amgen executive vice president of R&D Sean E Harper, MD said: “Treatment adherence can be a challenge with any oral medicine. If poorly controlled, sHPT may progress and can have significant clinical consequences.

“With Parsabiv, we can put the delivery of the therapy in the hands of the healthcare provider and help ensure that these patients receive this important treatment as part of their dialysis session three times a week.”

Parsabiv has now attained centralized marketing authorization with the approval from EC and can be marketed with unified labeling in 28 countries which are members of the European Union.

Members of European Economic Area, Norway, Iceland and Liechtenstein will take decisions as per accordance with EC.

Secondary Hyperparathyroidism refers to over production of parathyroid hormone by parathyroid glands in relation to impaired renal function and mineral metabolism.

Excess secretion of parathyroid hormone results in excessive release of calcium and phosphorous from bones. It often goes asymptomatically and undiagnosed and remains untreated.

Parsabiv being a calcimimetic agent mimics the action of calcium in the treatment of hyperparathyroidism in adult patients with chronic renal disease who are on dialysis.

It functions by activating the calcium sensing receptor on parathyroid gland thus reducing the levels of parathyroid hormone.