
FDA says no to Amgen’s Parsabiv
pharmafile | August 25, 2016 | News story | Research and Development, Sales and Marketing | Amgen, FDA, par
Amgen has announced that the US Food and Drug Administration (FDA) has issued a complete response letter rejecting Parsabiv (etelcalcetide) for the treatment of secondary hyperparathyroidism (sHPT) in adult patients with chronic kidney disease on hemodialysis.
Secondary hyperparathyroidism is a chronic and serious condition which affects the vast majority of people receiving dialysis, including 468,000 in the US alone. It refers to the excessive secretion of parathyroid hormone by the parathyroid glands in response to decreased renal function and impaired mineral metabolism, which leads to an increase in the release of calcium and phosphorus from the bones.
Parsabiv binds to and activates the calcium-sensing receptor on the parathyroid gland, thereby reducing levels of parathyroid hormone. It is administered intravenously at the end of the haemodialysis session.
In Phase III trials, it managed to induce a greater than 30% reduction in parathyroid hormone levels in three quarters of patients, compared to just 8.3% of patients on placebo.
Amgen has not indicated the reason behind the FDA’s rejection, but indicates that it anticipates a “post-action meeting with the FDA later this year to discuss complete response.” The company also indicates that this rejection does not impact regulatory submissions in other regions.
Sean Murray
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