The European Medicines Agency (EMA) Committee for Medicinal Products for Human Use (CHMP) had recommended approval of etelcalcetide (Parsabiv, Amgen Europe BV) for the treatment of secondary hyperparathyroidism (sHPT) in adults with chronic kidney disease (CKD) undergoing hemodialysis therapy.
Secondary hyperparathyroidism (sHPT) is a chronic and serious condition affecting many of the approximately 2 million people worldwide who are receiving dialysis, the company noted in a news release. In Europe, the prevalence of sHPT within dialysis populations ranges from 30% to 49%.
Etelcalcetide is a calcimimetic agent that binds to and activates the calcium-sensing receptor on the parathyroid gland, thereby decreasing parathyroid hormone (PTH) levels.
"If approved, Parsabiv will be the first calcimimetic agent that can be administered intravenously by a healthcare provider three times a week at the end of a hemodialysis session," the company noted.
Etelcalcetide will be available in 2.5-, 5-, and 10-mg vials containing a solution for injection.
The marketing authorization application for etelcalcetide included data from three phase 3 studies, all of which met their primary endpoints, including two pooled placebo-controlled trials in more than 1000 patients and a head-to-head study comparing Parsabiv with cinacalcet (Sensipar, Amgen), the company said.
The benefits of etelcalcetide include its ability to reduce abnormally elevated serum PTH levels in patients with CKD on hemodialysis therapy in order to mitigate the harmful effects of sHPT in these patients, the EMA added in a news release.
A decrease of serum calcium levels is the most common side effect. Other common side effects are muscle spasms, diarrhea, nausea, and vomiting.
Detailed recommendations for the use of etelcalcetide will be described in the summary of product characteristics, which will be published in the European public assessment report and made available in all official European Union languages after the European Commission grants marketing authorization.
On August 24, Amgen announced that the US Food and Drug Administration (FDA) has issued a Complete Response Letter for the New Drug Application for etelcalcetide for treatment of sHPT in adults with CKD on hemodialysis, thus delaying the drug's potential approval. Amgen said they anticipate a post-action meeting with the FDA later this year to discuss the letter.
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Cite this: CHMP Backs Etelcalcetide for Secondary Hyperparathyroidism - Medscape - Sep 16, 2016.