Amgen’s Parsabiv receives EC approval in secondary hyperparathyroidism

Amgen Inc., a leading American biopharmaceutical company, has achieved a significant milestone with the approval of its drug Parsabiv (etelcalcetide) by the European Commission (EC) for the treatment of secondary hyperparathyroidism (sHPT) in adult patients undergoing hemodialysis due to chronic renal disease.

Breakthrough in sHPT Management

sHPT is a complex and chronic condition that affects millions globally who are on dialysis. The condition leads to the overproduction of parathyroid hormone, which can cause severe complications including the excessive release of calcium and phosphorus from bones.

Parsabiv, which is a calcimimetic agent, works by mimicking the action of calcium on the parathyroid gland, effectively reducing the hormone levels. This mechanism plays a crucial role in managing the mineral and bone disorder associated with kidney disease.

Clinical Trials and Efficacy

The approval of Parsabiv was based on the positive results from three Phase 3 studies, which met their primary endpoints. These studies included two pooled placebo-controlled trials involving over 1,000 patients, and a head-to-head study comparing Parsabiv with cinacalcet. In the trials, Parsabiv demonstrated significant efficacy, with a substantial proportion of patients achieving more than a 30% reduction, and some even a 50% reduction, in mean parathyroid hormone levels during the Efficacy Assessment Phase (EAP) compared to baseline. Notably, Parsabiv was found to be superior to cinacalcet in these evaluations.

John Cunningham, MD, Professor of Nephrology at University College London Medical School, emphasized the importance of the new drug: “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.”

Sean E Harper, MD, Executive Vice President of R&D at Amgen, also highlighted the benefits of Parsabiv’s administration method: “Treatment adherence can be a challenge with any oral medicine. 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.”

Market Impact and Future Prospects

With its centralized marketing authorization, Parsabiv can now be marketed with unified labeling across 28 EU member countries, as well as in the European Economic Area members like Norway, Iceland, and Liechtenstein, following their respective approvals. This broad approval will facilitate the streamlined distribution and availability of Parsabiv, enhancing treatment accessibility for patients across Europe.

The EC’s approval of Parsabiv marks a pivotal advancement in the treatment landscape of sHPT, offering a more controlled and effective management option for patients. By ensuring consistent delivery during dialysis sessions, Parsabiv addresses one of the most significant hurdles in sHPT treatment—patient adherence to therapy.