Amgen Sensipar Label Prepares For Off-Label Use In Pre-Dialysis Market
This article was originally published in The Pink Sheet Daily
Executive Summary
Review documents show that FDA crafted the calcimimetic's label with the expectation of off-label use in secondary hyperparathyroidism patients not yet on dialysis. Concern about Sensipar's potential to cause QT prolongation via hypocalcemia was a key factor in FDA's rejection of Amgen's request for approval in the pre-dialysis population.
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