See the DrugPatentWatch profile for Parsabiv
Parsabiv, also known as etelcalcetide, is a calcimimetic agent used to treat secondary hyperparathyroidism (SHPT) in adult patients with chronic kidney disease (CKD) on hemodialysis [1]. Clinical trials have established its efficacy and safety profile for this indication.
How effective is Parsabiv in lowering PTH levels?
Clinical trials have demonstrated Parsabiv's ability to effectively reduce parathyroid hormone (PTH) levels in patients with SHPT. In a Phase 3 study, Parsabiv treatment resulted in a significant reduction of intact PTH (iPTH) levels, with 70% to 77% of patients achieving target iPTH levels (<300 pg/mL) by week 26 [2]. This effect was observed in both intravenous (IV) and subcutaneous (SC) administration groups [2].
What are the key clinical trials for Parsabiv?
Several pivotal clinical trials have supported the approval of Parsabiv. These include:
* Two Phase 3 trials (Trial 1 and Trial 2): These randomized, double-blind, placebo-controlled studies investigated the efficacy and safety of Parsabiv administered IV three times weekly following hemodialysis. They showed significant reductions in iPTH levels and phosphorus compared to placebo [3].
* A Phase 3 trial evaluating subcutaneous administration: This study demonstrated that SC Parsabiv was non-inferior to IV Parsabiv in reducing iPTH levels, suggesting an alternative administration route [2].
* A long-term extension study: This trial assessed the safety and tolerability of Parsabiv over an extended period, providing insights into its long-term use [4].
What is the safety profile of Parsabiv?
The most common adverse events reported in Parsabiv clinical trials include hypocalcemia, nausea, vomiting, diarrhea, and muscle spasms [3]. Hypocalcemia, defined as serum calcium <8.4 mg/dL, is a known risk with calcimimetics and requires careful monitoring and management [1][3]. Other serious adverse events observed include hyperkalemia and cardiac events [3].
How is Parsabiv administered in clinical trials?
In clinical trials, Parsabiv has been administered both intravenously (IV) and subcutaneously (SC) [2][3]. The IV route is typically given three times per week, following hemodialysis sessions. The SC route offers an alternative for patients who may not be suitable for IV administration [2].
What are the alternatives to Parsabiv for treating secondary hyperparathyroidism?
Other treatment options for SHPT include oral calcimimetics, such as cinacalcet, and vitamin D sterols [5]. The choice of treatment depends on individual patient factors, including disease severity, tolerability, and administration preferences [5].
When does the patent for Parsabiv expire?
Information on the specific patent expiry dates for Parsabiv can be found on DrugPatentWatch.com. This resource tracks patent information for pharmaceuticals, including expiry dates and any relevant litigation [6].