Etelcalcetide
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Trade names | Parsabiv |
Other names | Velcalcetide, telcalcetide, AMG-416, KAI-4169, ONO-5163 |
AHFS/Drugs.com | UK Drug Information |
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Intravenous injection | |
ATC code | |
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dialysate , 7% in urine and faeces | |
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Etelcalcetide (formerly velcalcetide, trade name Parsabiv) is a calcimimetic drug for the treatment of secondary hyperparathyroidism in patients undergoing hemodialysis. It is administered intravenously at the end of each dialysis session.[1][2] Etelcalcetide functions by binding to and activating the calcium-sensing receptor in the parathyroid gland.[1] Parsabiv is currently owned by Amgen and Ono Pharmaceuticals in Japan.[3][4]
Medical uses
Etelcalcetide is used for the treatment of secondary hyperparathyroidism in people with chronic kidney disease (CKD) on hemodialysis.[5] Hyperparathyroidism is the condition of elevated parathyroid hormone (PTH) levels and is often observed in people with CKD.[6]
Pharmacodynamics
Mechanism of action
Etelcalcetide functions by binding to and activating the
Pharmacokinetics
Etelcalcetide functions in a
No interaction studies in humans were conducted. Studies
Side effects
Common side effects (in more than 10% of people) are
Due to the lower iPTH levels achieved by the use of this drug, it is possible that adynamic bone disease could occur at levels "below 100 pg/mL"[4]
Contraindications
The drug is contraindicated in people with
Chemistry
The substance is a
History
Originally, Etelcalcetide was being developed by KAI Pharmaceuticals. After positive Phase II trials, Amgen acquired KAI for $315 Million.[9]
In 2011, KAI entered into agreement with Ono Pharmaceutical for production of Etelcalcetide in Japan, the deal being worth ¥1 Billion.[4]
On 25 August 2015
In February 2017, the FDA approved Parsabiv for the treatment of secondary hyperparathyroidism.[10]
Research
Phase II trials found that Etelcalcetide was able to lower PTH levels in one cohort by -49% vs a 29% increase in the placebo group.[4] In another Phase II study "89% of patients experienced a C30% reduction in PTH and 56% achieved a PTH level of B300 pg/mL."[4]
In 2017, two Phase III trials found that using etelcalcetide showed greater symptom reduction compared to placebo.[11] Etelcalcetide was also able to lower PTH levels below 300pg/mL more often.[11]
Phase I Pediatric studies are planned for the US and UK for etelcalcetide.[4]
References
- ^ a b c d "Amgen Submits New Drug Application For Novel Intravenous Calcimimetic Etelcalcetide (AMG 416)"
- PMID 24235081.
- ^ "Parsabiv New FDA Drug Approval | CenterWatch". www.centerwatch.com. Retrieved 2017-10-30.
- ^ S2CID 45000617.
- ^ a b c d e "Parsabiv: EPAR – Product Information" (PDF). European Medicines Agency. 24 November 2016.
- PMID 26266360.
- ^ a b c Haberfeld, H, ed. (2016). Austria-Codex (in German). Vienna: Österreichischer Apothekerverlag.
- ^ "Etelcalcetide". ChemSpider. Retrieved 7 January 2016.
- ^ "Amgen - Investors - Press Release". investors.amgen.com. Retrieved 2017-10-30.
- ^ "Parsabiv (etelcalcetide) Injection". www.accessdata.fda.gov. Retrieved 2017-10-30.
- ^ PMID 28381913.
Further reading
- HSRIC Fact sheet 2014 Archived 2016-03-04 at the Wayback Machine