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FDA Accepts Amgen's New Drug Application For Novel Intravenous Calcimimetic Etelcalcetide
THOUSAND OAKS, Calif., Nov. 6, 2015 /PRNewswire/ -- Amgen (NASDAQ:AMGN) today announced that the U.S. Food and Drug Administration (FDA) has accepted for review Amgen's New Drug Application (NDA) for etelcalcetide (formerly AMG 416) for the treatment of secondary hyperparathyroidism (SHPT) in patients with chronic kidney disease (CKD) on hemodialysis. If approved, etelcalcetide will be the first calcimimetic agent that can be administered intravenously.

"We're pleased that the FDA has accepted our submission and look forward to advancing our conversations toward a potential approval in the U.S.," said Sean E. Harper, M.D., executive vice president of Research and Development at Amgen. "Etelcalcetide has a novel method of administration that has the potential to help fill an unmet need for the many patients impacted by secondary hyperparathyroidism."

Etelcalcetide is a novel calcimimetic agent that suppresses the secretion of parathyroid hormone and is in clinical development for the treatment of SHPT in patients with CKD on hemodialysis. Etelcalcetide is administered intravenously three times per week at the end of each dialysis session. It acts by binding to and activating the calcium-sensing receptor on the parathyroid gland, thereby causing decreases in parathyroid hormone (PTH). Sustained elevations in PTH are known to be associated with significant clinical consequences for patients with CKD.

The NDA, submitted on Aug. 24, 2015, is based on data from three Phase 3 studies, including two pooled placebo-controlled trials in more than 1,000 patients and a head-to-head study evaluating etelcalcetide compared with cinacalcet.

The FDA has set a Prescription Drug User Fee Act (PDUFA) target action date of Aug. 24, 2016, for the etelcalcetide application.
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Source: press release, 11/06/15. http://wwwext.amgen.com/media/news-releases/2015/11/fda-accepts-amgens-n...

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Amgen Submits New Drug Application For Novel Intravenous Calcimimetic Etelcalcetide (AMG 416)

Potential New Treatment Option for the Management of Secondary Hyperparathyroidism in Patients With Chronic Kidney Disease Receiving Hemodialysis

THOUSAND OAKS, Calif., Aug. 25, 2015 /PRNewswire/ -- Amgen (NASDAQ: AMGN) today announced the submission of a New Drug Application (NDA) with the United States Food and Drug Administration (FDA) for etelcalcetide (formerly AMG 416) for the treatment of secondary hyperparathyroidism (SHPT) in patients with chronic kidney disease (CKD) on hemodialysis. If approved, etelcalcetide will be the first calcimimetic agent that can be administered intravenously at the end of the dialysis session.

"Secondary hyperparathyroidism is a serious, progressive disease that can lead to significant clinical consequences and is also associated with a high pill burden for patients," said Sean E. Harper, M.D., executive vice president of Research and Development at Amgen. "We look forward to working with regulatory authorities during the review process to bring this important treatment to market, helping to fill an unmet need for the many patients impacted by this disease."

Etelcalcetide is a novel calcimimetic agent that suppresses the secretion of parathyroid hormone and is in clinical development for the treatment of SHPT in patients with CKD on hemodialysis. Etelcalcetide is administered intravenously three times per week at the end of each dialysis session. It acts by binding to and activating the calcium-sensing receptor on the parathyroid gland, thereby causing decreases in parathyroid hormone (PTH). Sustained elevations in PTH are known to be associated with significant clinical consequences for patients with CKD.

The submission includes data from three Phase 3 studies, all of which met the primary endpoints, including two pooled placebo-controlled trials in more than 1,000 patients and a head-to-head study evaluating etelcalcetide compared with cinacalcet.
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Source: press release, 8/25/15. http://www.amgen.com/media/media_pr_detail.jsp?releaseID=2081807

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Compound/DeviceSpecialtyIndicationCompound ClassTarget
Etelcalcetide (AMG 416) Endocrine and MetabolismHyperparathyroidism (secondary)Peptide agonistcell surface calcium-sensing receptor (CaSR)

Mechanism of action: Etelcalcetide (AMG 416) is a peptide agonist of the human cell surface calcium-sensing receptor (CaSR). It is being investigated as a treatment for secondary hyperparathyroidism in patients with chronic kidney disease receiving dialysis.

Phase of Development: Filed

Event Type: Regulatory FDA: PDUFA DATE

Dates: 2016-08-24

Results: Pending