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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
"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
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
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
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/
This news release contains forward-looking statements that are based on the current expectations and beliefs of
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The scientific information discussed in this news release related to our product candidates is preliminary and investigative. Such product candidates are not approved by the
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.
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,
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