www.fdanews.com/articles/180552-amgen-secures-fda-approval-for-parsabiv-to-treat-secondary-hyperparathyroidism
Amgen Secures FDA Approval for Parsabiv to Treat Secondary Hyperparathyroidism
February 15, 2017
The FDA approved Amgen’s Parsabiv — the first drug designated to treat secondary hyperparathyroidism in more than a decade — after rejecting the candidate last summer.
The approval was based on two placebo-controlled Phase III studies that found Parsabiv showed a significant reduction in parathyroid hormone secretions. The drug met both the primary and secondary endpoints of the studies, Amgen said.
In August, the FDA refused to approve the drug, issuing a complete response letter to the company. Amgen did not release the contents of the rejection letter.