Amgen Receives Positive CHMP Opinion For Parsabiv™ (Etelcalcetide) For The Treatment Of Secondary Hyperparathyroidism In Adult Patients With Chronic Kidney Disease On Hemodialysis

THOUSAND OAKS, CA, USA I September 16, 2016 I Amgen (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.

About Secondary Hyperparathyroidism (sHPT)
sHPT is a chronic and serious condition which affects many of the approximately two million people throughout the world who are receiving dialysis.1-4 In Europe, the prevalence of sHPT within dialysis populations ranges from 30 to 49 percent.5 Approximately 88 percent of dialysis patients and 79 percent of patients on hemodialysis will develop sHPT.6 sHPT refers to the excessive secretion of parathyroid hormone (PTH) by the parathyroid glands in response to decreased renal function and impaired mineral metabolism.1 The elevated levels of PTH can lead to an increase in the release of calcium and phosphorus from the bones.7 sHPT is often initially silent and asymptomatic. As a result, sHPT is frequently underdiagnosed and undertreated.8

About Parsabiv™ (etelcalcetide)
Parsabiv is a novel calcimimetic agent in clinical development for the treatment of sHPT in adult CKD patients on hemodialysis that is administered intravenously at the end of the hemodialysis session. A calcimimetic is a drug that mimics the action of calcium by activating the calcium-sensing receptors on the parathyroid gland. Parsabiv binds to and activates the calcium-sensing receptor on the parathyroid gland, thereby decreasing PTH levels.

About Mimpara® (cinacalcet)
Mimpara® (cinacalcet) is the first oral calcimimetic agent approved by the EMA for the treatment of sHPT in patients with CKD on dialysis. The therapy is also approved in the EU for the treatment of hypercalcemia in patients with parathyroid carcinoma and hypercalcemia in adult patients with primary HPT for whom parathyroidectomy would be indicated on the basis of serum calcium levels (as defined by relevant treatment guidelines), but in whom parathyroidectomy is not clinically appropriate or is contraindicated. Mimpara binds to the calcium-sensing receptor, resulting in a drop in PTH levels by inhibiting PTH synthesis and secretion. In addition, the reductions in PTH lower serum calcium and phosphorus levels.

Important Safety Information
Mimpara lowers serum calcium; therefore, it is important that patients are carefully monitored for the occurrence of hypocalcaemia. Mimpara should not be initiated if serum calcium (corrected for albumin) is less than the lower limit of the normal range. The threshold for seizures is lowered by significant reductions in serum calcium levels. In the treatment of secondary hyperparathyroidism the most commonly reported adverse reactions in clinical trials were nausea and vomiting.

To see the full Mimpara Safety Information, visit www.ema.europa.eu/ema/

About Amgen
Amgen is committed to unlocking the potential of biology for patients suffering from serious illnesses by discovering, developing, manufacturing and delivering innovative human therapeutics. This approach begins by using tools like advanced human genetics to unravel the complexities of disease and understand the fundamentals of human biology.

Amgen focuses on areas of high unmet medical need and leverages its expertise to strive for solutions that improve health outcomes and dramatically improve people's lives. A biotechnology pioneer since 1980, Amgen has grown to be one of the world's leading independent biotechnology companies, has reached millions of patients around the world and is developing a pipeline of medicines with breakaway potential.

1 Official Journal of the International Society of Nephrology. KDIGO Clinical Practice Guideline for the Diagnosis, Evaluation, Prevention, and Treatment of Chronic Kidney Disease–Mineral and Bone Disorder (CKD–MBD). Available at: www.kdigo.org/clinical_practice_guidelines/pdf/CKD/KDIGO%20CKD-MBD%20GL%20KI%20Suppl%20113.pdf. Accessed July 28, 2016.
2 Kalantar-Zadeh K, Kuwae N, Regidor DL, et al. Survival predictability of time-varying indicators of bone disease in maintenance hemodialysis patients. Kidney Int. 2006;70:771-780.
3 National Kidney Foundation. Global Facts: About Kidney Disease. Available at: https://www.kidney.org/kidneydisease/global-facts-about-kidney-disease. Accessed July 28, 2016.
4 National Kidney Foundation. Fast Facts. Available at: https://www.kidney.org/news/newsroom/factsheets/FastFacts. Accessed July 28, 2016.
5 Hedgeman E, Lipworth L, Lowe K, et al. International Burden of Chronic Kidney Disease and Secondary Hyperparathyroidism: A Systematic Review of the Literature and Available Data. Int J Neph. 2015;2015: 184321.
6 Data on File, Amgen; 2016.
7 National Institutes of Health. MedlinePlus: Hyperparathyroidism. Available at: www.nlm.nih.gov/medlineplus/ency/article/001215.htm. Accessed July 28, 2016.
8 National Kidney Foundation. Parathyroid Hormone and Secondary Hyperparathyroidism in Chronic Kidney Disease. Available at: https://www.kidney.org/sites/default/files/02-10-4899_GB_SHPT-PTH_v8.pdf. Accessed July 28, 2016.

SOURCE: Amgen

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