Amgen announced the Journal of the American Medical Association (JAMA) publication of findings from three Phase 3 studies of Parsabiv (etelcalcetide), an investigational intravenous calcimimetic agent in the U.S. The studies evaluated Parsabiv in more than 1,700 adults with secondary hyperparathyroidism (sHPT) on hemodialysis and showed that the drug produced statistically significant and clinically meaningful reductions in serum parathyroid hormone (PTH) levels, a key marker of sHPT. sHPT is a chronic and serious condition that is often progressive among patients with chronic kidney disease (CKD) and is associated with significant clinical consequences. In two parallel Phase 3 randomized placebo-controlled studies in CKD patients with sHPT on hemodialysis, Parsabiv met the primary endpoint and significantly reduced serum PTH by more than 30% in 74.7% of patients compared to 8.9% given placebo. In addition, a head-to-head study comparing Parsabiv to oral Sensipar (cinacalcet) also met its primary endpoint. This head-to-head study showed Parsabiv was non-inferior to oral Sensipar in the proportion of patients achieving 30% or greater serum PTH reduction. Further, Parsabiv was superior to Sensipar for the secondary endpoints of proportion of patients achieving greater than 30% and greater than 50% reduction in mean PTH during the Efficacy Assessment Phase (EAP) compared with baseline. A total of 1,706 patients were enrolled across the three trials to evaluate the safety and efficacy of Parsabiv in the treatment of adult sHPT patients on hemodialysis. The two placebo-controlled trials were double-blind studies in a total of 1,023 adult patients with sHPT on hemodialysis. The patients were randomized to receive intravenous Parsabiv or placebo three times a week at the end of their dialysis sessions, and both arms also received standard of care as prescribed by the treating physician. Both of the trials showed that, by weeks 20-27, significantly more Parsabiv patients compared to placebo patients achieved: Greater than a 30% reduction from baseline in mean serum PTH during weeks 20-27: 74.0% versus 8.3% (p<0.001) and 75.3% versus 9.6% (p<0.001). Serum PTH levels of 300 pg/mL or less: 49.6% versus 5.1% (p<0.001) and 53.3% versus 4.6% (p<0.001). The most common treatment-emergent adverse events (TEAEs) in the placebo-controlled studies that occurred at a rate greater than 10% in the Parsabiv group, and more frequently than in the placebo group in either of the studies, were blood calcium decreases (asymptomatic reductions in serum calcium), muscle spasms, diarrhea, nausea and vomiting. The overall rates of fatal adverse events, serious adverse events and adverse events leading to discontinuation of investigational product were similar in the Parsabiv and placebo groups. The head-to-head study against Sensipar included 683 patients with sHPT on hemodialysis, and found Parsabiv resulted in a higher proportion of patients reaching at least a 30% reduction in mean serum PTH during weeks 20-27 compared to baseline: 68.2% versus 57.7%, respectively (p=0.004). Significantly more Parsabiv patients also achieved greater than a 50% reduction from baseline in mean serum PTH during weeks 20-27: 52.4% versus 40.2%, respectively (p=0.001). There was no statistically significant difference between the two groups in the mean number of days of vomiting or nausea per week in the first eight weeks, a secondary endpoint. TEAEs that were reported in greater than 10% of patients in either arm included blood calcium decreases, nausea, vomiting and diarrhea. TEAEs of hypocalcemia (symptomatic) were reported in 5.0% of patients who received Parsabiv versus 2.3% in the Sensipar group. In the U.S., the Parsabiv application has been resubmitted to the Food and Drug Administration (FDA) addressing the Complete Response Letter. The U.S. user fee goal date is Feb. 9, 2017. On Nov. 11, 2016, the European Commission (EC) granted marketing authorization for Parsabiv for the treatment of sHPT in adult patients with CKD on hemodialysis. Russian regulatory authorities approved Parsabiv on Dec. 5, 2016. Regulatory submissions for Parsabiv are currently pending in Colombia, Brazil, Switzerland and South Africa. On Dec. 19, 2016, Amgen's collaborator, Ono Pharmaceuticals, received manufacturing and marketing approval in Japan for Parsabiv for the treatment of secondary hyperparathyroidism in patients on hemodialysis.