Amgen has disclosed that its application for approval to market its kidney disease treatment Parsabiv™ (etelcalcetide) has been rejected by the FDA.

The company said it received a Complete Response Letter from the agency, but did not disclose the agency’s reason for the rejection in a terse announcement late yesterday. “The Complete Response Letter does not impact our regulatory submissions in other regions.”

“Amgen is reviewing the Complete Response Letter, and we anticipate a post-action meeting with the FDA later this year to discuss the Complete Response,” the company stated.

The FDA had set an August 24 Prescription Drug User Fee Act (PDUFA) target date for a decision on Amgen’s Parsabiv NDA, which the company said was based on data from three Phase III studies, including two pooled placebo-controlled trials in more than 1000 patients and a head-to-head study comparing etelcalcetide with Amgen’s marketed kidney drug Sensipar®/Mimpara® (cinacalcet), which met its primary endpoint of noninferiority to cinacalcet.

The NDA was accepted for agency review in November 2015. Two months earlier, Amgen filed a marketing authorization application with the European Medicines Agency.

Parsabiv is a peptide agonist of the human cell-surface calcium-sensing receptor (CaSR) indicated for treatment of secondary hyperparathyroidism (sHPT) in adults with chronic kidney disease on hemodialysis.

Administered intravenously at the end of a patient’s hemodialysis session, Parsabiv is a novel calcimimetic agent designed to work by binding to and activating the calcium-sensing receptor on the parathyroid gland, thus decreasing parathyroid hormone (PTH) levels.

Amgen envisioned Parsabiv as a successor treatment to Sensipar/Mimpara, which generated $1.415 billion in worldwide product sales last year (up 22% from 2014), and $756 million in the first 6 months of this year (up 11.5% from $678 million in January–June 2015).

Parsabiv was the lead product candidate of KAI Pharmaceuticals until Amgen bought the company in 2012 for $315 million cash.

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