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Amgen Submits Marketing Authorization Application For Novel Intravenous Calcimimetic Etelcalcetide (AMG 416) To The European Medicines Agency

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

THOUSAND OAKS, Calif., Sept. 2, 2015 /PRNewswire/ -- Amgen (NASDAQ: AMGN) today announced the submission of a Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) via the centralized procedure for etelcalcetide (formerly AMG 416) for the treatment of secondary hyperparathyroidism (SHPT) in adult patients with chronic kidney disease (CKD) on hemodialysis therapy. If approved, etelcalcetide will be the first calcimimetic agent that can be administered intravenously.

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.

"Secondary hyperparathyroidism affects many of the approximately two million people throughout the world on dialysis, yet there is currently no calcimimetic that can be administered intravenously at the end of scheduled dialysis sessions. Given that these patients take an average of 19 pills daily, there is an opportunity to improve their treatment as it relates to the administration of the therapy," said Sean E. Harper, M.D., executive vice president of Research and Development at Amgen. "Etelcalcetide has the potential to fill this unmet need, and we look forward to working with regulatory authorities in hopes of providing a new treatment option that could help improve the complex management of the disease."

The MAA submission for etelcalcetide includes data from three Phase 3 studies, all of which met their 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, 9/02/15. http://wwwext.amgen.com//media/media_pr_detail.jsp?year=2015&releaseID=2...

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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 EMA: CHMP Opinion (Estimate)

Dates: 2016-09-16

Results:

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European Commission Approves Parsabiv™ (etelcalcetide) For The Treatment Of Secondary Hyperparathyroidism In Adults On Hemodialysis
First Treatment Advance for Secondary Hyperparathyroidism in More Than a Decade and First Intravenous Calcimimetic to Help Healthcare Providers Lower Key Lab Values
THOUSAND OAKS, Calif., Nov. 11, 2016 /PRNewswire/ -- Amgen (NASDAQ:AMGN) today announced that the European Commission (EC) has granted marketing authorization for Parsabiv™ (etelcalcetide) for the treatment of secondary hyperparathyroidism (sHPT) in adult patients with chronic kidney disease (CKD) on hemodialysis. Parsabiv is the first calcimimetic agent that can be administered intravenously by a healthcare provider three times a week at the end of a hemodialysis session.

"Keeping relevant lab values in recommended target ranges is an important part of managing sHPT, a chronic and complex disease with an already complicated medication regimen for many patients," said John Cunningham, M.D., professor of nephrology at University College London Medical School. "Treatment failures are quite common and Parsabiv provides a new tool that should give physicians more confidence that patients are getting the medication they need to treat their sHPT."

The EC approved Parsabiv based on three Phase 3 studies, all of which met their primary endpoints, including two pooled placebo-controlled trials in more than 1,000 patients, and a head-to-head study with cinacalcet. Additionally, etelcalcetide was superior to cinacalcet for the secondary endpoints of proportion of patients achieving greater than 30 percent and greater than 50 percent reduction in mean parathyroid hormone (PTH) during the Efficacy Assessment Phase (EAP) compared with baseline.

"Treatment adherence can be a challenge with any oral medicine," said Sean E. Harper, M.D., executive vice president of Research and Development at Amgen. "If poorly controlled, sHPT may progress and can have significant clinical consequences. With Parsabiv, we can put the delivery of the therapy in the hands of the healthcare provider and help ensure that these patients receive this important treatment as part of their dialysis session three times a week."

Approval from the EC grants a centralized marketing authorization with unified labeling in the 28 countries that are members of the EU. Norway, Iceland and Liechtenstein, as members of the European Economic Area (EEA), will take corresponding decisions on the basis of the decision of the EC.
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Source: press release, 11/11/16. http://wwwext.amgen.com/media/news-releases/2016/11/european-commission-...

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Amgen Receives Positive CHMP Opinion For Parsabiv™ (Etelcalcetide) For The Treatment Of Secondary Hyperparathyroidism In Adult Patients With Chronic Kidney Disease On Hemodialysis
Novel Treatment Administered Intravenously Would put Delivery of Important Therapy in the Hands of the Healthcare Provider
THOUSAND OAKS, Calif., Sept. 16, 2016 /PRNewswire/ -- Amgen (NASDAQ:AMGN) today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion for the Marketing Authorization of Parsabiv™ (etelcalcetide), recommending approval for the treatment of secondary hyperparathyroidism (sHPT) in adult patients with chronic kidney disease (CKD) on hemodialysis. If approved, Parsabiv will be the first calcimimetic agent that can be administered intravenously by a healthcare provider three times a week at the end of a hemodialysis session.

"We are pleased to receive a positive CHMP opinion for Parsabiv, which has demonstrated strong efficacy in clinical trials and could help fill an unmet need in the delivery of this important therapy," said Sean E. Harper, M.D., executive vice president of Research and Development at Amgen. "Secondary hyperparathyroidism is a disease that affects many patients with advanced chronic kidney disease, and we look forward to continuing to work with regulatory authorities to provide these patients with a novel therapy and advance the management of this complex disease."

The Marketing Authorization Application (MAA) submission for Parsabiv included data from three Phase 3 studies, all of which met their primary endpoints, including two pooled placebo-controlled trials in more than 1,000 patients and a head-to-head study evaluating Parsabiv compared with cinacalcet.

The CHMP positive opinion will now be reviewed by the European Commission (EC), which has the authority to approve medicines for the European Union (EU). If approved, a centralized marketing authorization with unified labeling will be granted in the 28 countries that are members of the EU. Norway, Iceland and Liechtenstein, as members of the European Economic Area (EEA), will take corresponding decisions on the basis of the decision of the EC.
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Source: press release, 9/16/16. http://wwwext.amgen.com/media/news-releases/2016/09/amgen-receives-posit...

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