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Biotech Stocks Facing FDA Decision In August

Amgen Inc
Amgen Inc

Come August 24, 2016, and Amgen Inc. (AMGN) will know the FDA decision on Parsabiv (etelcalcetide), its proposed treatment for secondary hyperparathyroidism (SHPT) in patients with chronic kidney disease on hemodialysis.

Secondary hyperparathyroidism, or SHPT, is a common and serious condition that is often progressive among patients with chronic kidney disease, and it manifests as increased levels of parathyroid hormone as a result of increased production from the parathyroid glands. This disorder affects many of the approximately two million people throughout the world who are receiving dialysis, including 450,000 people in the U.S.

Parsabiv is a calcimimetic agent that works by suppressing the secretion of parathyroid hormone. Calcimimetic agents directly target the molecular mechanism that modulates calcium-regulated parathyroid hormone release.

Sensipar, the first oral calcimimetic agent approved by the FDA for the treatment of SHPT in adult patients with chronic kidney disease on dialysis, is also from Amgen’s stable. The drug garnered global sales of $1.42 billion in 2015, up 22% over the prior year.

If approved, Parsabiv will be the first calcimimetic agent that can be administered intravenously.