Amgen’s Parsabiv (etelcalcetide), a second-generation intravenous (IV) calcimimetic for the treatment of chronic kidney disease (CKD)-induced hyperparathyroidism in dialysis patients, has already gained regulatory approval in the US, Europe, and Japan within the past year.

The arrival of Parsabiv comes at an opportune time, a time in which Amgen’s first-generation oral calcimimetic agent Sensipar (cinacalcet), first approved in 2004, now faces patent expiration and generic erosion across multiple markets. GlobalData believes that Parsabiv will acquire a critical market position as the first IV calcimimetic in the CKD-induced hyperparathyroidism space.

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Similar to its in-family predecessor, Sensipar, Parsabiv is a positive allosteric modulator of the calcium-sensing receptor that acts to lower parathyroid hormone (PTH) levels by increasing calcium’s affinity for the receptor. Sensipar has generated blockbuster sales, bringing in more than $1.5B in worldwide sales last year alone, and key opinion leaders (KOLs) interviewed by GlobalData believe that Parsabiv has the potential to become a blockbuster as well.

Specifically, KOLs believe the IV formulation and tolerable safety profile of Parsabiv are important advantages in the CKD-induced hyperparathyroidism dialysis setting, as patient compliance with oral Sensipar is a major concern amongst physicians at present. A head-to-head Phase III trial with Sensipar also found Parsabiv to be superior to Sensipar in the proportion of patients achieving greater reduction in PTH levels from baseline.

Overall, Parsabiv has been evaluated in several Phase III studies, which most prominently include the positive results in a head-to-head study against first-in-class calcimimetic Sensipar, as well as encouraging results from placebo-controlled and long-term studies. KOLs believe the positive outcomes in these trials will significantly and positively impact Parsabiv’s uptake over the next decade, where it is predicted to cannibalise existing Sensipar market share.

CKD-induced hyperparathyroidism, which results in the increased production of PTH, is a condition that develops in response to declining kidney function. The risk of CKD-induced hyperparathyroidism increases with the severity of CKD. For more than a decade, since the introduction of Sensipar, there have been no novel calcimimetic treatments indicated specifically for CKD-induced hyperparathyroidism. By rolling out a second-generation IV-formulated calcimimetic, Amgen will continue to dominate this therapeutic space.

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Related reports

GlobalData (2017). OpportunityAnalyzer: Late-Stage Chronic Kidney Disease – Global Drug Forecast and Market Analysis to 2026, December 2017, GDHC012POA

GlobalData (2016). OpportunityAnalyzer: Hyperparathyroidism – Opportunity Analysis and Forecasts to 2025, December 2016, GDHC063POA