After a Decade of Pharmacological Drought, FDA Approves Amgen's Parsabiv™ (Etelcalcetide) - First New Treatment For Secondary Hyperparathyroidism

Chicago, IL - Hemodialysis patient population is burdened by many ailments and their pharmacological managements could be very challenging. Anemia due to chronic disease is one of them and while very prevalent among those patients, the invention of ESAs and careful management of iron stores has proven to be an effective strategy for its management. Diabetes, hypertension, and cardiovascular complications (e.g calciphylaxis ) complicate the clinical picture for many of this patients even further.

Bone mineral disease (BMD), on the other hand, is extremely common in those on long term  hemodialysis and its managemnt has experienced a pharmacological drought for over a decade with no new medications on the market. The main culprit for the increased incidence of bone-related issues, among others, are the declining renal function, elevated levels of phosphorous and high PTH, leading to bone resorption and ultimately increased mortality.

Parsabiv (etelcalcetide), manufactures by Amgen, is a new and excited medication for the treatment of secondary hyperparathyroidism in adults with chronic kidney disease on hemodialysis, which was approved in February 2017. Prior to Parsabiv, the armamentarium of pharmacological agents to treat BMD comprised of:

·    Calcimimetics: cinalcalcet (Sensipar)

·    Vitamin D analogues, and

·    Various Phosphorus binders

Parsabiv is expected to be made available to physicians and healthcare providers in January and the pilot treatment in our center has produced promising results for managing PTH levels and reducing the burden of BMD in patients on hemodialysis.

Please see a detailed article about Parsabiv here:

https://www.amgen.com/media/news-releases/2017/02/fda-approves-amgens-parsabiv-etelcalcetide-first-new-treatment-in-more-than-a-decade-for-secondary-hyperparathyroidism-in-adult-patients-on-hemodialysis/