That big new hyperparathyroidism drug from Amgen? The FDA rejected it
According to regular updates from Amgen over the past two years, investigators marched through a trio of late-stage studies for etelcalcetide (AMG416) with nothing but good things to report. The drug scored outstanding data for secondary hyperparathyroidism (SHPT), a disease that affects chronic kidney disease patients on hemodialyis.
And this evening Amgen reported that the drug was rejected by the FDA. The news came in a terse statement, without a hint about what the agency objected to.
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