Amgen's Parsabiv Receives EMA Approval for the Treatment of Secondary Hyperparathyroidism
European Regulatory Approval and Innovative Mechanism of Action
On November 11, 2016, Amgen, a global biotechnology company, announced that its treatment for secondary hyperparathyroidism (sHPT), Parsabiv (etelcalcetide), had received official marketing authorization from the European Medicines Agency (EMA). Parsabiv directly targets the calcium-sensing receptor (CaSR) in parathyroid cells, effectively suppressing the secretion of parathyroid hormone (PTH). This approval marks a new era in the treatment of sHPT, a serious complication experienced by adult patients with chronic kidney disease (CKD) undergoing hemodialysis. It establishes the legal basis for the commercial supply of this treatment across the 28 member states of the European Union.
Robust Efficacy Demonstrated Through Phase 3 Clinical Data
The pivotal Phase 3 program, which served as the basis for this approval, involved two placebo-controlled studies and one active-controlled study, encompassing over 1,000 dialysis patients. In the placebo-controlled clinical trial, 74.7% of patients in the Parsabiv group achieved a greater than 30% reduction in PTH levels from baseline, compared to 8.9% in the placebo group, demonstrating a significant difference in efficacy. Furthermore, in a head-to-head comparison with cinacalcet (Sensipar), the current standard first-generation oral treatment, the Parsabiv group achieved a 30% or greater reduction in PTH in 68.2% of patients, significantly outperforming the cinacalcet group (57.7%). This demonstrates that Parsabiv possesses superior efficacy in terms of biochemical control compared to existing drugs.
Improved Medication Adherence Through Intravenous Administration
The most innovative aspect of Parsabiv is its administration method: intravenous administration at the end of hemodialysis sessions, three times a week, as opposed to the daily oral administration required for existing treatments. Dialysis patients often take dozens of pills a day, leading to significant problems with medication adherence. Parsabiv eliminates the need for patients to actively manage their medication schedule, as it is administered directly by healthcare professionals during dialysis. This eliminates the possibility of missed doses and is expected to facilitate long-term biochemical control and reduce treatment failure rates in clinical practice.
Market Replacement and Commercial Value in a $1.7 Billion Market
Amgen developed Parsabiv to defend against the loss of revenue from Sensipar (Mimpara), its former blockbuster drug, due to patent expiration and the launch of generic versions. Sensipar generated global sales of $1.718 billion in 2017, making the approval of Parsabiv a critical defensive strategy. Amgen acquired Kai Pharmaceuticals for $315 million in 2012, securing this new drug, and has now achieved European approval. Although individual country pricing decisions and reimbursement coverage remain, the established Sensipar sales network is expected to facilitate a rapid market transition.
The EMA approval of Parsabiv provides Amgen (AMGN) with a crucial opportunity to maintain its leading position in the global secondary hyperparathyroidism (sHPT) market, valued at $1.718 billion, as the patent for its existing first-generation oral treatment, Sensipar, expires. The successful marketing of etelcalcetide, acquired through the $315 million acquisition of Kai Pharmaceuticals in 2012, validates Amgen's long-term strategy of addressing unmet medical needs and commercializing its new drug pipeline. The demonstration of superior efficacy in reducing PTH levels by 30% or more (68.2% vs. 57.7%) compared to the current standard oral treatment, cinacalcet, in Phase 3 trials, will serve as a strong defense against generic competition in the future, given its intravenous administration. Furthermore, the intravenous administration method is expected to fundamentally improve patient medication adherence, maximize long-term clinical benefits, and drive a paradigm shift in treatment practices.
Source: EMA (ema)