Amgen’s drug etelcalcetide (Parsabiv™) has been approved for marketing in Europe, through a decision by the European Commission announced in November 2016. Applications are also pending in the United States and Japan for etelcalcetide, which treats secondary hyperparathyroidism (SHPT) in adult patients with chronic kidney disease (CKD) who are on hemodialysis. In Europe, the prevalence of SHPT within dialysis populations ranges from 30% to 49%, Medscape reports. The EC approval covers 28 countries in the EU; Norway, Iceland, Liechtenstein, and members of the European Economic Area (EEA), can take corresponding decisions based on the EC decision.
The drug is the first calcimimetic agent to be given intravenously by a healthcare provider at the end of a hemodialysis session, three times weekly.
John Cunningham, MD, professor of nephrology at University College London Medical School, noted in Amgen’s announcement that treatment failures among patients with SHPT are common. “Parsabiv provides a new tool that should give physicians more confidence that patients are getting the medication they need to treat their SHPT,” Cunningham said.
In SHPT, excessive parathyroid hormone is secreted by the parathyroid gland and promotes phosphorus and calcium movement from bone, which can cause joint pain. The new medication binds to and activates the calcium-sensing receptor on the parathyroid gland and decreases parathyroid hormone levels.
The marketing 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, manufactured by Amgen).
Amgen submitted a new drug application for etelcalcetide to the US Food and Drug Administration in August 2015, but the FDA has yet to look favorably on the drug application. In August, the FDA issued a Complete Response Letter for the New Drug Application (NDA) for Parsabiv™.
According to the FDA website, a complete response letter provides a more consistent and neutral mechanism “to convey that our initial review of an application is complete and we cannot approve the application in its present form.” The agency said the letter provides a more consistent approach to informing applicants of changes that must be made before an application can be approved, with no implications about whether the drug will ultimately be approved. Amgen says it is reviewing the Complete Response Letter and anticipates a meeting with the FDA late in 2016.
In January 2016, Japanese drugmaker Ono Pharmaceuticals filed a manufacturing and marketing approval application in Japan for etelcalcetide, for the same indication, PharmaLetter.com reported. Ono has been working to commercialize the medication since 2011, when it entered into an exclusive licensing agreement with former KAI Pharmaceuticals (now a subsidiary of Amgen) to develop etelcalcetide.
