Amgen's Parasabiv Rejected by FDA
News Aug 26, 2016
Amgen has announced that the U.S. Food and Drug Administration (FDA) has issued a Complete Response Letter for the New Drug Application (NDA) for Parsabiv™ (etelcalcetide) for the treatment of secondary hyperparathyroidism (sHPT) in adult patients with chronic kidney disease (CKD) on hemodialysis.
The correspondence of a Complete Response Letter means that the FDA has decided that they will not approve Parsabiv in its present form.
Amgen is reviewing the Complete Response Letter, and anticipate a post-action meeting with the FDA later this year to discuss the Complete Response.
Amgen claim that the Complete Response Letter does not impact their regulatory submissions in other regions.