Posted by Michael Wonder on 17 Sep 2016
Amgen receives positive CHMP opinion for Parsabiv (etelcalcetide) for the treatment of secondary hyperparathyroidism in adult patients with chronic kidney disease on haemodialysis
16 September 2016 - Novel treatment administered intravenously would put delivery of important therapy in the hands of the health care provider.
Amgen today announced that the CHMP of the EMA has adopted a positive opinion for the marketing authorisation of Parsabiv (etelcalcetide), recommending approval for the treatment of secondary hyperparathyroidism in adult patients with chronic kidney disease (CKD) on hemodialysis.
If approved, Parsabiv will be the first calcimimetic agent that can be administered intravenously by a health care provider three times a week at the end of a hemodialysis session.
