Amgen's Parsabiv rejected for now by FDA

25 August 2016

The Food and Drug Administration has issued a Complete Response Letter (CRL) for the New Drug Application (NDA) for Parsabiv (etelcalcetide), a potential treatment for secondary hyperparathyroidism (sHPT) in adult patients with chronic kidney disease (CKD) on hemodialysis, from US biotech major Amgen (Nasdaq: AMGN).

Amgen is reviewing the CRL, and anticipates a post-action meeting with the FDA later this year to discuss the complete response.

Parsabiv is a follow-on to its already marketed Sensipar/Mimpara (cinacalcet). The FDA accepted the Parsabiv NDA for review last November, setting a Prescription Drug User Fee Act (PDUFA) target action date of August 24, 2016,

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