Amgen's new generation of calcimimetic Etecatide will soon be approved for marketing in China

Recently, CDE's official website announced that the listing application of Amgen's new drug etelcalcetide hydrochloride injection (etelcalcetide, trade name Parsabiv) has been accepted by CDE ^[1] .

Before understanding this drug, let's first understand why patients with lower kidney disease develop SHPT.

SHPT is one of the common complications in patients with chronic kidney disease (CKD) that seriously affects the prognosis and quality of life of patients ^[2] .

SHPT can be treated with drugs to control hyperphosphatemia and maintain blood calcium levels up to the standard.

At present, there are three calcimimetics approved for marketing worldwide, namely Cinacalcet (Cinacalcet), Etelcalcetide, and Evocalcet.

01

The mechanism of action of three calcimimetic agents

A calcimimetic is an allosteric agonist that acts on calcium sensitive receptors (CaSR).

On the one hand, Cinacalcet can increase the sensitivity of extracellular calcium ion by regulating the calcium-sensitive receptors of the parathyroid glands, thereby inhibiting the synthesis of PTH.

The mechanism of action of etecartide is similar to that of cinacalcet.

Evocalcet is currently the latest calcimimetic with similar pharmacological effects to cinacalcet.

02

Clinical Efficacy of Etecartide

Etecatide vs placebo ^[5]

The approval of etacatide was mainly based on a phase 3 randomized controlled study, which included 1023 patients with moderate to severe SHPT.

The results found that the number of patients in the etacatide group who reached the primary endpoint was significantly higher than that in the placebo group (74.

Etecatide vs Cinacalcet ^[5]

In a study comparing the efficacy of etecartide and cinacalcet, a total of 683 patients with moderate to severe SHPT were included.

The results found that the effectiveness of etecartide was similar to that of cinacalcet, and the proportion of patients whose PTH level dropped by more than 30% from baseline was 68.

It can be seen that the efficacy of etacatide is better than placebo and no less than cinacalcet.

03

market expectation

As the first approved oral calcimimetic, Cinacalcet was first approved for marketing in the United States in March 2004 under the trade name Sensipar; in December of the same year, it was approved for marketing in Europe under the trade name Mimpara.

In 2015, Cinacalcet's sales exceeded US$1 billion.

After its launch in 2017, Etecartide's sales have risen year by year.
In 2020, sales will reach 716 million U.
S.
dollars.
It is expected to become a blockbuster product with sales exceeding one billion U.
S.
dollars.

Evocalcet was approved in Japan in March 2018 for the treatment of secondary hyperparathyroidism in maintenance dialysis patients.
The drug is currently in the phase III clinical stage in China.

Parathyroid gland is an essential gland for human life.
SHPT is a common and serious decompensation disease in chronic kidney disease patients undergoing dialysis treatment.
It is one of the important manifestations of mineral metabolism disorders and is also an end-stage maintenance of chronic kidney disease.
One of the most important and serious complications of dialysis patients during dialysis.

The results of the 2012 Chinese epidemiological survey showed that the number of patients with end-stage renal disease in China is about 2 million, the dialysis rate is less than 20%, and the conversion rate of SHPT in patients with mineral and bone metabolism disorders (CKD-MBD) is close to 50%.
.
The dialysis rate in developed countries (the United States, Europe, Japan) is 90%.

Based on this, it can be predicted that the number of SHPT in my country in the future will release a larger room for growth as the diagnosis, detection, and treatment of chronic kidney disease improve.

reference:

1.
Retrieved May 18, 2021, from