To continue reading this article, sign up for FREE to
Membership is FREE
and provides you with
instant access
to email newsletters, digital publications, our full content catalogue & more...
Amgen's Parasabiv Rejected by FDA
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.
Add Technology Networks as a preferred Google source to see more of our trusted coverage.
