The Journal of the American Medical Association has published findings from three Phase 3 studies of Amgen’s 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.
In two parallel Phase 3 randomized placebo-controlled studies in CKD patients with sHPT on hemodialysis, Parsabiv significantly reduced serum PTH by more than 30% in 74.7% of patients compared to 8.9% in patients given placebo.
A head-to-head study comparing Parsabiv to oral Sensipar (cinacalcet) also met its primary endpoint and showed Parsabiv was non-inferior to oral Sensipar in the proportion of patients achieving 30% or greater serum PTH reduction. Parsabiv was superior 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 compared with baseline.
Amgen said it has resubmitted the drug’s application U.S. to the Food and Drug Administration addressing the Complete Response Letter the company received in August.The U.S. user fee goal date is Feb. 9, 2017
In November, the European Commission 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.
Amgen said regulatory submissions are currently pending in Colombia, Brazil, Switzerland and South Africa. In December, Amgen’s collaborator, Ono Pharmaceuticals, received manufacturing and marketing approval in Japan for Parsabiv for the treatment of secondary hyperparathyroidism in patients on hemodialysis.