MFDS, approval of Vadadustat for anemia tx of renal disease

Used to treat chronic patients undergoing hemodialysis

Vadadustat, which is used to treat anemia in patients with chronic kidney disease, has received domestic product approval.

 

The Ministry of Food and Drug Safety (Minister Yu-Kyoung Oh) announced on the 13th that it had approved two doses (150 and 300mg) of Vadadustat from Mitsubishi Tanabe Pharma Korea Co., Ltd., a new drug for the treatment of anemia in patients with chronic kidney disease.

 

Vadadustat is a treatment for anemia in adult patients with chronic kidney disease undergoing hemodialysis.

 

Vadadustat is a treatment for anemia in adult patients with chronic kidney disease undergoing hemodialysis.

 

The drug promotes red blood cell production by inhibiting proline hydroxylase, which breaks down hypoxia-inducible factor (HIF).

 

Sufficient iron stores should be ensured when Vadadustat treatment is initiated, and transferrin saturation (TSAT) and ferritin concentrations should be checked.

 

If not previously treated with erythropoiesis-stimulating agents (ESAs), the criterion for initiation of this drug is a hemoglobin (Hb) concentration of less than 10 g/dL.

 

Patients receiving erythropoiesis-stimulating agents (ESAs) may be switched to this drug.

 

As Vadadustat, 300mg once a day is orally administered as a starting dose, and after the start of treatment, the dose is appropriately increased or decreased according to the patient's condition.

 

The highest dose can be up to 600 mg once daily.

 

If looking at the precautions for use, there is a risk of death due to serious thromboembolic events such as stroke, cerebral infarction, myocardial infarction, deep vein thrombosis, and pulmonary embolism during the administration of this drug.

 

Since the administration of this drug may cause liver dysfunction, liver function tests should be performed regularly.

 

The Ministry of Food and Drug Safety said, "We will continue to do our best to expand treatment opportunities for patients by promptly supplying treatments whose safety and effectiveness have been sufficiently confirmed based on regulatory scientific expertise."