New anemia tablets offer increased options

raises patients' hope for expanded options in anemia with CKD

EAS injections dominate the Korean market…top-line growth reaches KRW 100 billion

AZ’a ‘Evrenzo,’ JW’s ‘Enaroy,’ and Mitsubishi’s Vadanem were approved in 2021, 2022, and 2023, respectively

Identified efficacy and effect in clinical trial…significantly improved convenience in intake

Whether the introduction of tablet formulations that offer improved convenience in intake in the KRW 100 billion renal anemia treatment market will shift the market paradigm and offer new options for anemia patients is gaining attention.

 

Until now, erythropoietin stimulating agents were the mainstream treatment for anemia caused by chronic kidney disease, but in 2021, 2022, 2023, AstraZeneca·JW Pharmaceutical·Mitsubishi Tanabe Pharma Korea each received approval for their Evrenzo Tab(Roxadustat)· Enaroy Tab(Enarodustat)· Vadanem Tab(Vadadustat) from the Ministry of Food and Drug Safety, respectively, and showed the new potential held by hypoxia-inducible factor-prolyl hydroxylase inhibitors (HIF-PHI).

 

According to drug distribution data, the size of Korea’s domestic renal anemia treatment market is around KRW 100 billion, and the same market is worth KRW 10 trillion in overseas markets where HIF-PHI is also prescribed Evrenzo, which was approved in Korea in 2021, can be administered to patients regardless of dialysis status to treat symptomatic anemia in patients with chronic kidney disease.

 

Patients can benefit from its use as switching from ESA agents is allowed.

 

Evrenzo activates the hypoxia-inducible factor (HIF), which regulates gene expression by regulating the formation of red blood cells.

 

It targets the HIF and reversibly inhibits HIF-proline hydroxylase (HIF-PH).

 

This stimulates the natural response that normally occurs when oxygen levels are low, including the production of erythropoietin and hemoglobin, reducing the symptoms of anemia.

 

Its high efficacy has been confirmed in three clinical trials (ANDES, OLYMPUS, ALPS), and the trials confirmed that the drug can maintain hemoglobin concentration in patients who switch from ESA therapy.

 

The drug, which was co-developed by AstraZeneca and FibroGen, was first approved in China in December 2018 and was approved in Japan the following year.

 

JW Pharmaceutical’s Vadanem which was approved in 2022 is indicated for the treatment of adult patients with chronic kidney disease who are receiving hemodialysis.

 

It is a HIF-PH inhibitor that stimulates ‘erythropoietin,’ a hormone that promotes the production of red blood cells while reducing ‘hepcidin,’ which regulates iron metabolism to improve the patient’s hemoglobin level.

 

Unlike existing injections, it was developed as an oral formulation and is offered in 3 doses-1 mg, 2 mg, and 4 mg - improving the convenience of intake for the patients.

 

In 2016, JW Pharmaceutical signed a licensing agreement with the Japanese company Japan Tobacco for the domestic development and distribution rights of 'JTZ-951', a new drug candidate for anemia of CKD.

 

Afterward, the efficacy and safety of JTZ-951 were proven through Phase III bridging trials at 28 domestic hospitals.

 

The trial confirmed the candidate’s non-inferiority to the existing treatment.

 

‘darbepoetin alfa.’ Mitsubishi Tanabe Pharma Korea’s new anemia treatment for patients with chronic kidney disease, Vadanem, was also approved by the Ministry of Food and Drug Safety in March this year.

 

This drug is also indicated as a treatment for adult patients with chronic kidney disease who are receiving hemodialysis.

 

It promotes red blood cell production by inhibiting proline hydroxylase, which degrades hypoxia-inducible factor (HIF).

 

At the time of its approval, the Ministry of Food and Drug Safety, said, “The MFDS will continue being committed to the rapid provision of safe and effective treatment for the Korean people based on its expertise in regulatory science.” Evrenzo Tab, Enaroy, and Vadanem are all tablet (pill) formulations that offer significantly improved convenience over existing injection formulations.

 

They are evaluated to be highly cost-effective in treating patients.

 

Meanwhile, renal anemia is a common complication in patients with kidney disease that is caused by abnormal kidney function.

 

The kidneys secrete erythropoietin (EPO), a hormone that promotes the production and maturation of red blood cells and helps the bone marrow that facilitate the production of red blood cells.

 

However, when EPO production capacity decreases along with kidney function decline, hematopoiesis decreases, leading to anemia.

 

Renal anemia reduces the patient's activity as it reduces energy production in organs due to a lack of red blood cells and lack of oxygen supply.

 

It is also accompanied by fatigue, loss of appetite, decreased exercise ability, insomnia, and depression, lowering the quality of life and also affecting the patient's mortality rate.

 

Currently, there are more than 700 million people with chronic kidney disease around the world, and 1 in 7 are known to suffer from anemia.

 

Since it takes a long time for the symptoms of renal anemia to appear, many patients are known to lack awareness of their condition.