The European Commission (EC) has granted marketing authorization for Parsabiv (etelcalcetide), Amgen’s candidate for treating secondary hyperparathyroidism (sHPT) in adult patients with chronic kidney disease (CKD) who are undergoing hemodialysis.
Parsabiv is a new calcimimetic agent that is administered intravenously three times a week at the end of the dialysis session.
Calcimimetics are drugs that mimic the action of calcium by activating calcium-sensing receptors on the parathyroid gland. This lowers parathyroid hormone (PTH) levels, which are excessively high in sHPT patients.
“Keeping relevant lab values in recommended target ranges is an important part of managing sHPT, a chronic and complex disease with an already complicated medication regimen for many patients,” John Cunningham, MD, a professor of nephrology at University College London Medical School, said in a press release.
“Treatment failures are quite common and Parsabiv provides a new tool that should give physicians more confidence that patients are getting the medication they need to treat their sHPT,” he said.
The approval was based on results from two parallel Phase 3 clinical trials (NCT01785849, NCT01788046) involving more than 1,000 patients, and a head-to-head study (NCT01896232) that compared Parsabiv, administrated intravenously, with Amgen’s Sensipar (cinacalcet), an oral medication.
Data found most Parsabiv-treated patients achieved a greater than 30 percent and greater than 50 percent reduction in mean PTH at studies’ end. In the head-to-head trial, Parsabiv was seen to be superior to Sensipar.
“Treatment adherence can be a challenge with any oral medicine,” said Sean E. Harper, MD, executive vice president of Research and Development at Amgen. “If poorly controlled, sHPT may progress and can have significant clinical consequences. With Parsabiv, we can … help ensure that these patients receive this important treatment as part of their dialysis session three times a week.”
Parsabiv will now be available in the 31 European countries that the European Medicines Agency covers.
The U.S. Food and Drug Administration approved Parsabiv in February to also treat adult CKD patients who are on dialysis and experience sHPT.
Amgen is now beginning an open-label clinical trial (NCT02833857) to evaluate the safety and drug properties of Parsabiv in pediatric patients ages 2 to 17, with sHTP at the end of hemodialysis. That trial, taking place in Belgium, Germany, and Lituania, is expected to soon begin recruiting participants. More information is available on its clinical trials.gov webpage.