Amgen's new generation of kidney disease drug Parsabiv approved by FDA

The new generation of kidney disease drug Parsabiv(etelcalcetide) developed by American biotech giant Amgen (Amgen) has recently received good news from the US regulatory side. The US Food and Drug Administration (FDA) has approved the Parsabiv for the treatment of secondary hyperparathyroidism (sHPT, referred to as secondary hyperparathyroidism) in patients with chronic kidney disease (CKD) undergoing hemodialysis. It is worth mentioning that Amjin originally expected to get the US listing approval in 2016, but a complete response letter issued by FDA in August last year made Amjin's expectation come to naught. In the EU, Parsabiv was approved for listing by the European Commission (EC) in November 2016.

This approval makes Parsabiv the first new drug in the field of secondary hyperparathyroidism (sHPT) in the past 10 years. It is also the first intravenous calcimimetic to be administered three times a week after each dialysis.

The approval of the Parsabiv was based on data from three phase III clinical studies, two of which were placebo-controlled studies and the other was a head-to-head study, all of which met the primary endpoint. Head-to-head Phase III data released in February last year showed that Parsabiv efficacy easily beat Amjin's own listed product Sensipar(cinacalcet, cinacalcet), which is the first oral calcimimetic approved by FDA for the treatment of secondary hyperparathyroidism (sHPT) in adult patients with chronic kidney disease receiving dialysis treatment, with sales exceeding US $1.6 billion in 2016. The industry is very optimistic about Parsabiv's commercial prospects and believes that the drug will become another blockbuster product for Amjin.

Secondary hyperparathyroidism (SHPT, referred to as secondary hyperparathyroidism) refers to the chronic renal insufficiency, intestinal malabsorption syndrome, Fanconi syndrome and renal tubular acidosis, vitamin D deficiency or resistance and pregnancy, lactation and other circumstances, parathyroid long-term hypocalcemia, hypomagnesemia or hyperphosphatemia stimulation and excessive secretion of parathyroid hormone (PTH), A chronic compensatory clinical manifestation of elevated serum calcium, magnesium, and decreased serum phosphorus, long-term parathyroid hyperplasia eventually leads to the formation of a functionally autonomous adenoma.

Parsabiv, a novel calcimimetic agent that inhibits the secretion of parathyroid hormone (PTH), is being developed for the treatment of secondary hyperparathyroidism (sHPT) in patients with chronic kidney disease (CKD) undergoing hemodialysis, administered intravenously three times a week after each dialysis session. Secondary hyperparathyroidism (SHPT) is a common and severe decompensation disease in CKD patients undergoing dialysis therapy. It is now known that persistently elevated parathyroid hormone (PTH) is associated with key clinical outcomes in patients with CKD. etelcalcetide binds to and activates calcium-sensing receptors on the parathyroid glands, leading to a decrease in parathyroid hormone (PTH) levels.

In addition, according to the investigation, Amjin has applied for a patent for Parsabiv(etelcalcetide) on March 25, 2016, and the priority date is March 26, 2015. Although the patent has not been authorized and is still under review, the current situation of 56 pages of patent text is enough to imagine the importance Amjin attaches to this patent. Associated with the patent dispute between Sanofi and Amjin on cholesterol drugs pushed by Hua Xun on January 23, and the current patent of Amjin that can only be searched for with etelcalcetide as the key word, this blockbuster new product of Amjin should not fall into patent dispute in the short term. And this time to obtain FDA approval, for Amjin is undoubtedly another big guarantee of income.

News source:http://news.bioon.com/article/6698076.html

This news was re-edited and reorganized by the Huaxun team and added analytical comments.