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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.

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